Roche Molecular Systems Inc COBAS TaqMan 48 Analyzers. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
COBAS TaqMan 48 Analyzers.
Brand
Roche Molecular Systems Inc
Lot Codes / Batch Numbers
COBAS TaqMan 48 Analyzer Serial Numbers: 1184, 1077, 1084, 1131, 1135, 1139, 1141, 1143, 1144, 1180, 1185, 1236, 1284, 1453, 1454, 391174, 391171, 1343, 1186, 1052, 1241, 1340, 1045, 1240, 1367, 1402, 1342, 1237, 1244, 1401, 1112, 1175, 1058, 1142, 1039, 1439, 1245, 1111, 1341, 1348, 1057, 1179, 1397, 1246, 1299, 1366, 1339, 1177, 1347, 1113, 1137, 1238, 1242, 1346, 1368, 1298, 1440, 1132, 1147, 1114, 1182, 1398, 1145, 1089, 1183, 1140, 1047, 1133, 1138, 1247, 1396, 1369, 1118, 1181, 1243.
Products Sold
COBAS TaqMan 48 Analyzer Serial Numbers: 1184; 1077; 1084; 1131; 1135; 1139; 1141; 1143; 1144; 1180; 1185; 1236; 1284; 1453; 1454; 391174; 391171; 1343; 1186; 1052; 1241; 1340; 1045; 1240; 1367; 1402; 1342; 1237; 1244; 1401; 1112; 1175; 1058; 1142; 1039; 1439; 1245; 1111; 1341; 1348; 1057; 1179; 1397; 1246; 1299; 1366; 1339; 1177; 1347; 1113; 1137; 1238; 1242; 1346; 1368; 1298; 1440; 1132; 1147; 1114; 1182; 1398; 1145; 1089; 1183; 1140; 1047; 1133; 1138; 1247; 1396; 1369; 1118; 1181; 1243.
Roche Molecular Systems Inc is recalling COBAS TaqMan 48 Analyzers. due to Improper seating of a fiber optic cable which may cause pixel cross-talk leading to falsely elevated test results or cases of misalignment to sample-t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Improper seating of a fiber optic cable which may cause pixel cross-talk leading to falsely elevated test results or cases of misalignment to sample-to-result mismatch.
Recommended Action
Per FDA guidance
An Urgent Product Recall letter was sent to all customers with a COBAS TaqMan 96 and 48 analyzer on 5/24/2004 by overnight delivery with delivery confirmation. On May 25, 2004, All Roche Field Service Engineers were instructed to inspect the analyzers to confirm that the cables were properly seated.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MD, VA
Page updated: Jan 10, 2026