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U.S. Department of Health and Human Services

Class 2 Device Recall Synchron System(s) Lactate Reagent

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 Class 2 Recall
Synchron System(s) Lactate Reagent
see related information
Date Posted June 27, 2013
Recall Status1 Terminated on June 03, 2014
Recall Number Z-1613-2013
Recall Event ID 65377
Product Classification Acid, Lactic, Enzymatic Method - Product Code KHP
Product SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX® System(s), UniCel® DxC 600/800 System(s) and Synchron® Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).
Code Information Part Number A95550, Lot Number M210077
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea, California 92821-6232
Manufacturer Reason
for Recall
Beckman Coulter has confirmed customer reports of LACT Lot M210077 failing calibration with error condition OCR LOW. The calibration failures appear to be related to improper shipping or storage conditions (frozen reagent). Failed calibration of LACT may cause a delay in reporting results.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Beckman Coulter Inc. sent an Urgent Product Correction letter dated May 28, 2013 to affected customers. The letter identified the affected product, the issue, impact, actions to be taken, and resolution. The letter instructed customers to discontinue use of the affected product and request a replacement product. For questions contact Customer Support Center (Call Center) on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support/ or call 800-854-3633 in the United States and Canada. Outside the United States or Canada, contact your local Beckman Coulter Representative.
Quantity in Commerce 3,353 units
Distribution Worldwide Distribution - USA Nationwide and country of Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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