Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid).
FDA device recall Z-0935-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Product was found to produce higher recoveries by about 7-12% compared to other lots.
- Action taken
- Users were requested to discard and ask for replacement of the lot in question by letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- KLT
- Quantity affected
- unknown
- Distribution
- Nationwide and Canada
- Date initiated
- 2003-06-11
- Date posted
- 2004-07-20
- Date terminated
- 2004-05-10
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM (K955644) | Beckman Instruments, Inc. | 1996-02-16 |