COBAS TaqMan analyzer, Series 96; catalog number 8080216.
FDA device recall Z-0917-03 · posted 2003-06-05 · Terminated
Recall details
- Recalling firm
- Roche Molecular Systems Inc
- Reason for recall
- A false positive result may be reported.
- Action taken
- Each customer was informed of the recall by telephone on March 6, 2003. Customers were instructed to check each postiive result to see if the 'RFITOOLOW' flag was generated, and follow-up instructions were provided. A recall letter was also faxed and mailed to each customer on March 6, 2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJF
- Quantity affected
- 16
- Distribution
- Nationwide. California, Colorado, Georgia, Illinois, Maryland, Missouri, New Jersey, New Mexico, North Carolina, Utah and Virginia.
- Date initiated
- 2003-03-06
- Date posted
- 2003-06-05
- Date terminated
- 2003-12-10
- 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 |