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U.S. Department of Health and Human Services

Class 2 Device Recall Synchron Systems LX20/ UniCel DxC ISE Reference Reagent

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 Class 2 Recall
Synchron Systems LX20/ UniCel DxC ISE Reference Reagent
see related information
Date Posted August 10, 2013
Recall Status1 Terminated on August 10, 2013
Recall Number Z-1951-2013
Recall Event ID 65655
Premarket Notification
510(K) Number
K965240 
Product Classification Electrode, Ion Specific, Potassium - Product Code CEM
Product ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium concentration in human serum, plasma or urine.
Code Information Lot No. T006042
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea, California 92821-6232
For Additional Information Contact Clair K. O'Donovan, Ph.D.
714-961-4483
Manufacturer Reason
for Recall
Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because it has a potassium (K) response near the instrument calibration flag limits and may exceed the limits on some instruments.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Beckman Coulter Inc sent an Urgent Product Corrective Action (PCA) letter dated September 22, 2010 to all affected customers. Customers were notified of the the problems identified and the actions to be completed. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to 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 US and in Canada.
Quantity in Commerce 718 units total (132 units in US)
Distribution Worldwide Distribution - USA Nationwide and the countries of Belgium, France, Germany, Netherlands, Poland, Spain, Sweden, Switzerland, and United Kingdom
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.
510(K) Database 510(K)s with Product Code = CEM and Original Applicant = BECKMAN INSTRUMENTS, INC.
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