Recall Z-1173-2012 ยท DLZ Enzyme Immunoassay, Phenobarbital
Beckman Coulter Inc.
Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. The Beckman Coulter SYNCHRON Systems DRUG CALIBRATOR 1, when used in conjunction with SYNCHRON reagents, is intended for use on the SYNCHRON Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, Theophylline, and Valproic Acid.
| Date | Mar 6, 2012 (initiated Aug 11, 2009) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the lots of Phenobarbital (PHE) reagent and calibrator. |
| Root cause | Nonconforming Material/Component |
| Action | Beckman Coulter sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated August 26, 2009 to all customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were instructed to share the recall information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. Customers were asked to complete and return a response form. Contact Beckman Coulter Customer Support Center (Hotline) at (800) 854-3633 for questions regarding this recall. |
| Quantity | 78,585 units total (75,385 in the US) |
| Distribution | Worldwide Distribution--USA (nationwide) and the country of 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 |