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U.S. Department of Health and Human Services

Class 2 Device Recall Synchron Phenobarbital (PHE) Reagent

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  Class 2 Device Recall Synchron Phenobarbital (PHE) Reagent see related information
Date Initiated by Firm August 11, 2009
Date Posted March 06, 2012
Recall Status1 Terminated 3 on December 05, 2013
Recall Number Z-1174-2012
Recall Event ID 60937
510(K)Number K955644  
Product Classification Calibrators, drug mixture - Product Code DKB
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.
Code Information M810083 and earlier
Recalling Firm/
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer 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 2
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 in Commerce 31,559 units total (30,617 units in the US)
Distribution Worldwide Distribution--USA (nationwide) and the country of Canada.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DKB and Original Applicant = BECKMAN INSTRUMENTS, INC.