FDA Medical Device Recalls (openFDA)
Roche Molecular Systems Inc: COBAS TaqMan 48 Analyzers.
- Recall number
- Z-1120-04
- Recalling firm
- Roche Molecular Systems Inc
- Product
- COBAS TaqMan 48 Analyzers.
- Status
- Terminated
- Initiated
- 2004-05-24
- Posted
- 2004-07-27
- Terminated
- 2006-03-08
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 75
- Distribution
- Units are sold to hospitals, clinics, and clinical laboratories thoughout the US. There are 10 VA hospitals. There is one government agency, NIH, Bethesda, MD.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K012966"]
- PMA numbers
- not on file
- Product code
- JJF
- Firm FEI
- 1000121742
- Firm city
- Belleville
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28