Recall Z-0935-04 ยท KLT Enzyme Immunoassay, Carbamazepine
Beckman Coulter Inc
Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid).
| Date | Jul 20, 2004 (initiated Jun 11, 2003) |
| Status | Terminated |
| Reason | Product was found to produce higher recoveries by about 7-12% compared to other lots. |
| Root cause | Other |
| Action | Users were requested to discard and ask for replacement of the lot in question by letter. |
| Quantity | unknown |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955644 | SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM Beckman Instruments, Inc., Feb 16, 1996 |