COBAS TaqMan 48 Analyzers.
FDA device recall Z-1120-04 · posted 2004-07-27 · Terminated
Recall details
- Recalling firm
- Roche Molecular Systems Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJF
- Quantity affected
- 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.
- Date initiated
- 2004-05-24
- Date posted
- 2004-07-27
- Date terminated
- 2006-03-08
- Location
- Belleville, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ROCHE COBAS TAQMAN ANALYZER (K012966) | Roche Molecular Systems, Inc. | 2002-02-01 |