Recall Z-1174-2012
Beckman Coulter Inc. · initiated August 11, 2009
Product
Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. PHE reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 1, is intended for quantitative determination of Phenobarbital concentration in human serum or plasma.
Codes / lots: M810083 and earlier
Reason for recall
The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the lots of Phenobarbital (PHE) reagent and calibrator.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1174-2012
- Initiated
- August 11, 2009
- Posted by FDA
- March 6, 2012
- Terminated
- December 5, 2013
- Product code
- DKB – Calibrators, Drug Mixture
- Quantity
- 31,559 units total (30,617 units in the US)
- Distribution
- Worldwide Distribution--USA (nationwide) and the country of Canada.
- Recalling firm
- Beckman Coulter Inc., Brea, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1173-2012 | Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600, Classification Product Code:…The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the… | 08/11/2009Terminated |