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U.S. Department of Health and Human Services

Class 2 Device Recall Beckman Unicel DxC 600 and DxC 800 Clinical Systems

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 Class 2 Recall
Beckman Unicel DxC 600 and DxC 800 Clinical Systems
see related information
Date Posted June 23, 2011
Recall Status1 Terminated on July 02, 2012
Recall Number Z-2633-2011
Recall Event ID 55276
Premarket Notification
510(K) Numbers
K042291  K060256 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product Tubing Assembly #142, V2, V12 Mixer/Wash a component of the DxC instruments. Tube, Assembly, #142 V2, V12 Mixer/Wash delivers appropriate amount of wash concentrate on the UniCel DxC SYNCHRON Clinical Systems. The UniCel DxC Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent)
Code Information All serial numbers
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
200 S Kraemer Blvd
Brea, California 92821-6208
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
The recall was initiated because the Wash Concentrate Tube Assembly 142 may fail to deliver the appropriate amount of wash concentrate on some SYNCHRON DxC Systems due to an accumulation of crystals. The impact of this issue would include: (1) Quality Control and patient results can potentially be affected. (2) If system has been calibrating properly and Quality Control is recovering within es
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Beckman Coulter sent out an "Urgent Product Corrective Action" letter dated July 23, 2009 and mailed the week of July 27, 2009 to all affected customers. The letter provides the cusotmers with explanation of the problem identifed and asks them to take the following actions: " If consignees are not able to resolve these issues through routine troubleshooting they were told to contact BCI Customer Technical Support at (800) 854-3633 in the United States and Canada. " This issue will be corrected with an upcoming software version and tubing modification. " Complete and return the enclosed response form within 10 days so that Beckman Coulter may maintain their records. Consignees were also asked to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. Questions regarding this Product Corrective Action letter were directed to their Customer Technical Support Center (Hotline) at (800) 854-3633 in the United States and Canada.
Quantity in Commerce 2392 units
Distribution Worldwide Distribution - USA (Nationwide) and 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.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = BECKMAN COULTER, INC.
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