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Recalls affecting Colorado

Data last updated: September 6, 2026 at 11:49 PM UTC

16,627 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
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UnclassifiedRisk not yet known
Medical deviceRecalled November 13, 2002

Gambro ClinicalKit Safety Kit 15G, Catalog Number 0141080405C. Packaged 30 kits per case. Each kit contains 2 Nipro Safetouch Safety Needles.

Gambro's ClinicalKit 15G safety Kits contain the Nipro Safetouch Safety Fistula Needles currently being recalled by Nipro for leakage problems

COILMOVA
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FDA has not published a risk classification for this recall yet.

Recall #:
25023
Lot/product code:
Gambro ClinicalKit Safety Kit 15G. Catalog No. 0141080405C. Lots 05H154001, 04H154007, 04H154010, 04H154011..
Recalling firm:
Gambro Renal Products
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 14, 2002

GEM DR Model 7271 Implantable Cardioverter-Defibrillator (ICD)

Extended charge times prior to defibrillation shock.

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FDA has not published a risk classification for this recall yet.

Recall #:
25041
Lot/product code:
All serial numbers beginning with PIM4. The serial number have the form of PIM4xxxxxx.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 20, 2004

BD Vacutainer Microtainer Serum tubes (with or without gel).

"Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-0052-05). The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is an apparent bias in the determination of Total T3, Total T4, HBsAg, Folate BA, VB 12, BR, FSH and Cortisol hormones used to determine thyroid disease states, and

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FDA has not published a risk classification for this recall yet.

Recall #:
30104
Lot/product code:
There is no linkage to any particular lot of BD product.
Recalling firm:
Becton Dickinson & Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 20, 2004

BD Vacutainer Partial Draw serum tubes (with or without gel).

"Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-0052-05). The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is an apparent bias in the determination of Total T3, Total T4, HBsAg, Folate BA, VB 12, BR, FSH and Cortisol hormones used to determine thyroid disease states, and a

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FDA has not published a risk classification for this recall yet.

Recall #:
30104
Lot/product code:
There is no linkage to any particular lot of BD product.
Recalling firm:
Becton Dickinson & Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 20, 2004

BD Vactuainer SST glass and plastic tubes.

"Please be aware tht this not a new recall. The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is an apparent bias in the determination of Total T3, Total T4, HBsAg, Folate BA, VB 12, BR, FSH and Cortisol hormones used to determine thyroid disease states, and adrenal gland function. The immunoassay results are high when

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FDA has not published a risk classification for this recall yet.

Recall #:
30104
Lot/product code:
There is no linkage to any particular lot of BD product.
Recalling firm:
Becton Dickinson & Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2005

Bard Composix Kugel Large Oval, 5.4'' x 7'' for hernia repairs Product Code: 0010202

Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula. (Extension of recall Z-0524/0526-06)

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FDA has not published a risk classification for this recall yet.

Recall #:
34393
Lot/product code:
Lot Numbers: 41*L****, 41*M****, 41*N**** 43*L****, 43*M****, 43*N****
Recalling firm:
Davol, Inc., Sub. C. R. Bard, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2005

Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 10.8'' x 13.7'' (25.4cm x 33cm) Code: 0010207

Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula

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FDA has not published a risk classification for this recall yet.

Recall #:
34393
Lot/product code:
Lot Codes: 41XMXXXX ¿ M = 2002, 41XNXXXX ¿ N = 2003, 43XMXXXX ¿ M = 2002, 43XNXXXX ¿ N = 2003, 43XOXXXX ¿ O = 2004, 43XPXXXX ¿ P = 2005.  If the lot number does not contain either M, N, O or P as the 4th character the lot is not affected by this recall.
Recalling firm:
Davol, Inc., Sub. C. R. Bard, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2005

Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 7.7'' x 9.7'' (19.6cm x 24.6cm) Code: 0010208

Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
34393
Lot/product code:
Lot Codes: 41XMXXXX ¿ M = 2002, 41XNXXXX ¿ N = 2003, 43XMXXXX ¿ M = 2002, 43XNXXXX ¿ N = 2003, 43XOXXXX ¿ O = 2004, 43XPXXXX ¿ P = 2005.  If the lot number does not contain either M, N, O or P as the 4th character the lot is not affected by this recall.
Recalling firm:
Davol, Inc., Sub. C. R. Bard, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2005

Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7'' x 10.7'' Code: 0010206

Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
34393
Lot/product code:
Lot Codes: 41XMXXXX ¿ M = 2002, 41XNXXXX ¿ N = 2003, 43XMXXXX ¿ M = 2002, 43XNXXXX ¿ N = 2003, 43XOXXXX ¿ O = 2004, 43XPXXXX ¿ P = 2005.  If the lot number does not contain either M, N, O or P as the 4th character the lot is not affected by this recall.
Recalling firm:
Davol, Inc., Sub. C. R. Bard, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2005

Bard Composix Kugel Large Circle, 4.5'' for hernia repairs Product Code: 0010204

Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula. (Extension of recall Z-0524/0526-06)

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FDA has not published a risk classification for this recall yet.

Recall #:
34393
Lot/product code:
Lot Numbers: 41*L****, 41*M****, 41*N**** 43*L****, 43*M****, 43*N****
Recalling firm:
Davol, Inc., Sub. C. R. Bard, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2005

Bard Composix Kugel Oval, 6.3'' x 12.3'' for hernia repairs Product Code: 0010209

Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula. (Extension of recall Z-0524/0526-06)

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FDA has not published a risk classification for this recall yet.

Recall #:
34393
Lot/product code:
All Lot Numbers
Recalling firm:
Davol, Inc., Sub. C. R. Bard, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 10, 2007

Bard Composix Kugel Hernia Patch- Large Circle 4.5'' with ePTFE Product Code: 0010204

PET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula

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FDA has not published a risk classification for this recall yet.

Recall #:
36990
Lot/product code:
Lot Numbers: 43AOD 43LOD  43BOD 43APD  43COD 43BPD  43DOD 43CPD  43EOD 43DPD  43FOD 43EPD  43GOD 43FPD  43HOD 43GPD  43IOD 43HPD 43JOD 43IPD  43KOD; Market Withdrawal: 43JPD 43DQD  43KPD 43EQD  43LPD 43FQD 43AQD 43GQD  43BQD 43HQD  43CQD 43IQD* *Redesigned products will be clearly indicated on the  label. Any product of this lot with the word 'Redesigned' on the label is not part of this Market Withdrawal.
Recalling firm:
Davol, Inc., Sub. C. R. Bard, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 10, 2007

Bard Composix Kugel Hernia Patch- Large Oval with ePTFE , 5.4'' x 7.0'' Product Number: 0010202

PET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
36990
Lot/product code:
Recalled Lot Numbers: 43AOD 43LOD  43BOD 43APD  43COD 43BPD  43DOD 43CPD  43EOD 43DPD  43FOD 43EPD  43GOD 43FPD  43HOD 43GPD  43IOD 43HPD 43JOD 43IPD  43KOD; Market Wthdrawal Lot Numbers: 43JPD 43DQD  43KPD 43EQD  43LPD 43FQD 43AQD 43GQD  43BQD 43HQD  43CQD 43IQD* *Redesigned products will be clearly indicated on the  label. Any product of this lot with the word 'Redesigned' on the label is not part of this Market Withdrawal.
Recalling firm:
Davol, Inc., Sub. C. R. Bard, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 18, 2010

PROCEED Surgical Mesh; Product Code PCDG1; :Lot BMG618; Ethicon, Inc. a Johnson & Johnson Company. Used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

There is a potential for delamination in one lot of Proceed surgical mesh.

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FDA has not published a risk classification for this recall yet.

Recall #:
57021
Lot/product code:
Product code PCDG1, Lot number BMG618.
Recalling firm:
Ethicon, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 17, 2011

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.

Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.

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FDA has not published a risk classification for this recall yet.

Recall #:
98868
Lot/product code:
1. Product Code: 0042-0000-CA. GTIN: 00813502011272. Serial Numbers: IC1324, IC1346, IC1480, IC1481, IC1543, IC1544, IC1572, IC1595, IC1598, IC1664, IC1665, IC1715. 2. Product Code: 0042-0000-EU. GTIN: 00813502011289. Serial Numbers: IC1217, IC1265, IC1275, IC1276, IC1288, IC1284, IC1301, IC1302, IC1304, IC1305, IC1344, IC1341, IC1343, IC1340, IC1345, IC1350, IC1347, IC1349, IC1383, IC1381, IC1384, IC1386, IC1393, IC1396, IC1397, IC1395, IC1413, IC1415, IC1411, IC1416, IC1490, IC1488, IC1522, IC1523, IC1524, IC1525, IC1547, IC1549, IC1546, IC1548, IC1578, IC1577, IC1579, IC1580, IC1594, IC1584, IC1590, IC1592, IC1591, IC1585, IC1588, IC1653, IC1676, IC1685, IC1684, IC1677, IC1678, IC1699, IC1700. 3. Product Code: 0042-0000-UK. GTIN: 00813502011296. Serial Numbers: IC1387, IC1389, IC1388, IC1519, IC1542, IC1545, IC1581, IC1582, IC1583, IC1573. 4. Product Code: 0042-0000-US. GTIN: 00813502010022. Serial Numbers: IC1004, IC1002, IC1001, IC1006, IC1007, IC1008, IC1014, IC1015, IC1017, IC1019, IC1024, IC1025, IC1028, IC1029, IC1026, IC1027, IC1033, IC1035, IC1031, IC1032, IC1036, IC1037, IC1038, IC1039, IC1041, IC1042, IC1044, IC1049, IC1043, IC1046, IC1053, IC1055, IC1052, IC1040, IC1030, IC1056, IC1047, IC1051, IC1050, IC1060, IC1061, IC1062, IC1064, IC1065, IC1066, IC1067, IC1074, IC1070, IC1071, IC1072, IC1073, IC1068, IC1069, IC1058, IC1075, IC1076, IC1077, IC1078, IC1079, IC1084, IC1085, IC1083, IC1080, IC1088, IC1086, IC1087, IC1081, IC1082, IC1100, IC1099, IC1093, IC1095, IC1089, IC1094, IC1096, IC1097, IC1106, IC1102, IC1105, IC1104, IC1108, IC1103, IC1107, IC1110, IC1115, IC1120, IC1111, IC1112, IC1114, IC1116, IC1117, IC1119, IC1133, IC1113, IC1132, IC1124, IC1134, IC1135, IC1136, IC1137, IC1138, IC1140, IC1141, IC1142, IC1139, IC1144, IC1143, IC1121, IC1122, IC1123, IC1147, IC1148, IC1145, IC1146, IC1149, IC1150, IC1151, IC1152, IC1153, IC1154, IC1157, IC1158, IC1159, IC1156, IC1162, IC1163, IC1164, IC1165, IC1166, IC1167, IC1168, IC1169, IC1170, IC1171, IC1174, IC1175, IC1172, IC1173, IC1178, IC1160, IC1176, IC1177, IC1179, IC1180, IC1181, IC1182, IC1186, IC1155, IC1183, IC1185, IC1184, IC1187, IC1191, IC1188, IC1189, IC1161, IC1190, IC1192, IC1193, IC1196, IC1219, IC1218, IC1194, IC1197, IC1198, IC1199, IC1213, IC1222, IC1226, IC1221, IC1225, IC1214, IC1220, IC1223, IC1224, IC1227, IC1211, IC1212, IC1208, IC1210, IC1215, IC1209, IC1202, IC1201, IC1200, IC1207, IC1203, IC1205, IC1206, IC1204, IC1235, IC1234, IC1228, IC1230, IC1231, IC1233, IC1229, IC1236, IC1237, IC1238, IC1239, IC1240, IC1242, IC1244, IC1245, IC1243, IC1250, IC1247, IC1258, IC1246, IC1251, IC1252, IC1254, IC1256, IC1257, IC1253, IC1255, IC1261, IC1264, IC1259, IC1262, IC1263, IC1269, IC1274, IC1272, IC1270, IC1271, IC1273, IC1291, IC1300, IC1296, IC1297, IC1289, IC1290, IC1293, IC1298, IC1299, IC1295, IC1292, IC1294, IC1306, IC1310, IC1309, IC1307, IC1311, IC1313, IC1314, IC1312, IC1315, IC1316, IC1317, IC1319, IC1321, IC1320, IC1322, IC1325, IC1331, IC1328, IC1330, IC1332, IC1326, IC1327, IC1333, IC1336, IC1329, IC1335, IC1342, IC1338, IC1339, IC1337, IC1334, IC1358, IC1356, IC1357, IC1353, IC1354, IC1355, IC1351, IC1352, IC1364, IC1365, IC1360, IC1361, IC1362, IC1363, IC1359, IC1379, IC1377, IC1380, IC1375, IC1376, IC1372, IC1374, IC1378, IC1373, IC1382, IC1390, IC1400, IC1408, IC1406, IC1409, IC1394, IC1403, IC1401, IC1405, IC1407, IC1402, IC1404, IC1410, IC1412, IC1414, IC1417, IC1418, IC1421, IC1422, IC1423, IC1419, IC1420, IC1425, IC1426, IC1431, IC1424, IC1429, IC1427, IC1430, IC1428, IC1440, IC1441, IC1434, IC1435, IC1436, IC1437, IC1442, IC1443, IC1432, IC1433, IC1438, IC1439, IC1450, IC1446, IC1448, IC1368, IC1444, IC1445, IC1449, IC1462, IC1461, IC1469, IC1466, IC1467, IC1470, IC1473, IC1474, IC1475, IC1465, IC1453, IC1454, IC1460, IC1471, IC1472, IC1459, IC1463, IC1464, IC1455, IC1458, IC1451, IC1452, IC1456, IC1457, IC1478, IC1484, IC1485, IC1476, IC1477, IC1479, IC1483, IC1482, IC1489, IC1491, IC1492, IC1486, IC1496, IC1495, IC1507, IC1513, IC1505, IC1506, IC1512, IC1514, IC1510, IC1497, IC1499, IC1517, IC1518, IC1515, IC1516, IC1508, IC1501, IC1502, IC1503, IC1504, IC1500, IC1509, IC1498, IC1536, IC1532, IC1531, IC1533, IC1540, IC1538, IC1529, IC1541, IC1537, IC1539, IC1527, IC1526, IC1534, IC1535, IC1528, IC1530, IC1557, IC1556, IC1550, IC1553, IC1554, IC1552, IC1555, IC1551, IC1562, IC1563, IC1564, IC1566, IC1567, IC1568, IC1569, IC1570, IC1571, IC1565, IC1575, IC1558, IC1559, IC1560, IC1561, IC1574, IC1599, IC1603, IC1604, IC1605, IC1596, IC1618, IC1600, IC1601, IC1602, IC1606, IC1607, IC1608, IC1609, IC1610, IC1612, IC1613, IC1614, IC1615, IC1616, IC1617, IC1628, IC1621, IC1622, IC1623, IC1624, IC1625, IC1626, IC1627, IC1639, IC1637, IC1638, IC1629, IC1630, IC1640, IC1631, IC1632, IC1633, IC1634, IC1635, IC1636, IC1648, IC1642, IC1650, IC1644, IC1645, IC1646, IC1651, IC1652, IC1641, IC1643, IC1663, IC1654, IC1655, IC1660, IC1661, IC1662, IC1656, IC1657, IC1658, IC1659, IC1674, IC1666, IC1669, IC1673, IC1672… (truncated, 5281 characters total — see the official FDA record for the full value)
Recalling firm:
Abiomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 28, 2011

Raymond Laser alignment guide - Model #1096597/001 Green Laser. Intended to assist operators in performing material handling activities such as storing and retrieving pallets and material in and on racking projecting a line onto a pallet or other material storage medium for assisting the operator in determining the position of the powered industrial truck forks with respect to load.

Raymond shipped a laser alignment guide as an option on its powered industrial trucks from February 2, 2010 through April 21, 2011, but was not aware of its obligation under 21 C.F.R. 1010.2 and 1010.3 to certify and label.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
60528
Lot/product code:
Model #1096597/001
Recalling firm:
The Raymond Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 28, 2011

Raymond Laser alignment guide - Model #1096597/002 Red Laser. Intended to assist operators in performing material handling activities such as storing and retrieving pallets and material in and on racking projecting a line onto a pallet or other material storage medium for assisting the operator in determining the position of the powered industrial truck forks with respect to load.

Raymond shipped a laser alignment guide as an option on its powered industrial trucks from February 2, 2010 through April 21, 2011, but was not aware of its obligation under 21 C.F.R. 1010.2 and 1010.3 to certify and label.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
60528
Lot/product code:
Model #1096597/002
Recalling firm:
The Raymond Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 28, 2011

Raymond Laser alignment guide - Model #1096597/001 Green Laser. Intended to assist operators in performing material handling activities such as storing and retrieving pallets and material in and on racking projecting a line onto a pallet or other material storage medium for assisting the operator in determining the position of the powered industrial truck forks with respect to load.

Raymond shipped a laser alignment guide as an option on its powered industrial trucks from February 2, 2010 through April 21, 2011, but was not aware of its obligation under 21 C.F.R. 1010.2 and 1010.3 to certify and label.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
60528
Lot/product code:
Model #1096597/001
Recalling firm:
The Raymond Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 28, 2011

Raymond Laser alignment guide - Model #1096597/002 Red Laser. Intended to assist operators in performing material handling activities such as storing and retrieving pallets and material in and on racking projecting a line onto a pallet or other material storage medium for assisting the operator in determining the position of the powered industrial truck forks with respect to load.

Raymond shipped a laser alignment guide as an option on its powered industrial trucks from February 2, 2010 through April 21, 2011, but was not aware of its obligation under 21 C.F.R. 1010.2 and 1010.3 to certify and label.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
60528
Lot/product code:
Model #1096597/002
Recalling firm:
The Raymond Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2012

Product is a 15x16x27" (WxDxH) air purifier device with one of two different brands next to the control panel: HealthWay or CleanStation. HealthWay brand is sold under model number Deluxe 20600-3 Air Purification System. The CleanStation brand is sold under model number CS20000. The devices are intended to remove particles from the air for medical purposes

The Company is recalling certain serial numbers of HealthWay Model 20600-3 and CleanStation Model CS20000 air purifiers because of a potential risk of electrical arcing that could cause overheating or fire within the units.

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FDA has not published a risk classification for this recall yet.

Recall #:
60968
Lot/product code:
08070001-08070425, 01080001-01080420, 13070001-13070415, 10080001-10080455, 33070001-33070458, 21080001-21080355, 34070001-34070455, 22080001-22080420, 35070001-35070455, 28080001-28080455, 36070001-36070455, 21080001-21080190, 38070001-38070395, 47080001-47080410, 39070001-39070455, 49080001-49080423, 45070001-45070195, 50080001-50080420, 42070001-42070455, 35090001-35090447, 43070001-43070455
Recalling firm:
Healthway Home Products, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 25, 2012

IMMULITE/IMMULITE 1000 CK-MB LKMB --- Catalog number: LKMB1 (100 tests), LKMB5 (500 tests) --- Test code: CMB Color: Dark Blue. For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.

Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructions for Use (IFU). This difference applies to all IMMULITE platforms.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
61029
Lot/product code:
kit lot 312, 313
Recalling firm:
Siemens Healthcare Diagnostics
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 25, 2012

IMMULITE/IMMULITE Turbo 1000 CK-MB LSKCP --- Catalog number: LSKCP1 (100 tests), LSKCP5 (500 tests) --- Test code: RCK Color: Orange. For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.

Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructions for Use (IFU). This difference applies to all IMMULITE platforms.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
61029
Lot/product code:
kit lot 316, 318
Recalling firm:
Siemens Healthcare Diagnostics
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 25, 2012

IMMULITE 2500 CK-MB L5KCP --- Catalog number: L5KCP2 (200 tests), L5KCP6 (600 tests) --- Test code: RCK Color: Orange. For in vitro diagnostic use with the IMMULITE 2500 Analyzer --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.

Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructions for Use (IFU). This difference applies to all IMMULITE platforms.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
61029
Lot/product code:
kit lot 136, 137
Recalling firm:
Siemens Healthcare Diagnostics
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 25, 2012

IMMULITE 2000/IMMULITE 2000 XPi CK-MB L2KMB --- Catalog number: L2KMB2 (200 tests), L2KMB6 (600 tests) --- Test code: CMB Color: Dark Blue. For in vitro diagnostic use with the IMMULITE 2000 Analyzers --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.

Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructions for Use (IFU). This difference applies to all IMMULITE platforms.

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FDA has not published a risk classification for this recall yet.

Recall #:
61029
Lot/product code:
kit lot 213, 214, 215
Recalling firm:
Siemens Healthcare Diagnostics
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UnclassifiedRisk not yet known
Medical deviceRecalled February 2, 2012

VITROS Chemistry Products --- ALT Slides --- [REF] 165 5281 --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc., Rochester, NY USA. The recalled device is the calibration disk contained within the VITROS Calibrator Kit 3. The is can be identified with the label "VITROS Chemist y Systems --- Universal Calibration Diskette --- [REF] 871 6607 --- Ortho-Clinical Diagnostics" For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 3 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of AcP, ALT, ALKP, AMYL, AST, CK, GGT, LDH, and LIPA.

Ortho Clinical Diagnostics received complaints of lower than expected results (< 6 U/L) for samples that were known to be outside of the measuring (reportable) range (> 1000 U/L) when using Calibration Diskette/Assay Data Diskette Data Release Version (DRV) 5653 through 5666 and VITROS Chemistry Products ALT Slides, Generation (GEN) 26 (Product Code 1655281).

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FDA has not published a risk classification for this recall yet.

Recall #:
61175
Lot/product code:
Calibration Diskette (Product Code 8716607) and the Assay Data Diskette (Product Code 6801876), Data Release Version (DRV) 5653 through 5666 used in conjuction with of VITROS¿ Chemistry Products ALT Slides, Generation (GEN) 26 (Product Code 1655281).
Recalling firm:
Ortho-Clinical Diagnostics
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