Recall Z-1173-2012

Beckman Coulter Inc. · initiated August 11, 2009

Terminated

Product

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.

Codes / lots: M810440 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-1173-2012
Initiated
August 11, 2009
Posted by FDA
March 6, 2012
Terminated
December 5, 2013
Product code
DLZ – Enzyme Immunoassay, Phenobarbital
Quantity
78,585 units total (75,385 in the US)
Distribution
Worldwide Distribution--USA (nationwide) and the country of Canada.
Recalling firm
Beckman Coulter Inc., Brea, CA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1174-2012 Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification Product Code: KLT.…The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the… 08/11/2009Terminated