—#106838

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.

FDA product code: DKB — Calibrators, Drug Mixture
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K955644
Affected lot / code info: M810083 and earlier

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Worldwide Distribution--USA (nationwide) and the country of Canada.

Timeline

Recall initiated: 2009-08-11
Posted by FDA: 2012-03-06
Terminated: 2013-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106838. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.