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U.S. Department of Health and Human Services

Class 2 Device Recall Synchron Acetaminophen (ACTM) Reagent

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 Class 2 Device Recall Synchron Acetaminophen (ACTM) Reagentsee related information
Date Initiated by FirmJuly 10, 2008
Date PostedSeptember 25, 2008
Recall Status1 Terminated 3 on July 11, 2012
Recall NumberZ-2405-2008
Recall Event ID 49069
510(K)NumberK000494 
Product Classification Reagent - Product Code LDP
ProductSynchron Acetaminophen (ACTM) Reagent, Part Number 472169. ACTM Reagent when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 Systems and SYNCHRON Systems Drug Calibrator 2 set, is intended for quantitative determination of Acetaminophen concentration in human serum or plasma.
Code Information Lot Numbers M703276 and M702524
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information ContactNora Zerounian
714-961-3634
Manufacturer Reason
for Recall		This recall was initiated after Beckman Coulter verified through testing that Acetaminophen reagents (lots #M702524 & M703276) manufactured with contaminated heparin has shown a negative bias in performance between the assay made with contaminated and uncontaminated heparin.
FDA Determined
Cause 2		Process control
ActionThe initial customer notifications with fax back response forms were mailed via US Postal Service beginning on 07/21/2008. The letter asked their customers to please discontinue use and discard appropriately the affected lots of Synchron Acetaminophen Reagent (M703276 & M702524). Customers were also instructed to contact their Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada or, if they are outside the US or Canada, please contact your local Beckman Coulter Representative to discuss replacement options. They were also instructed to complete and return the enclosed response form within 10 days. In addition, the customers were informed that the contaminated Heparin was used in the following Beckman Coulter, Inc., products: Synchron Theophylline (THE) Reagent (lot # M701460), Synchron Phenytoin (PHY) Reagent and Synchron C-Reactive Protein (CRP) Reagent (lot# M703222, M703266, M703267 & M703268), however Beckman Coulter has verified through testing that the performance of these products are not affected.
Quantity in Commerce7764 test kits
DistributionNationwide and Canada
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LDP
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