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U.S. Department of Health and Human Services

Class 2 Device Recall Beckman Coulter UniCel DxC 880i, 860i, and 600i Systems

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 Class 2 Recall
Beckman Coulter UniCel DxC 880i, 860i, and 600i Systems
see related information
Date Posted September 30, 2010
Recall Status1 Terminated on July 02, 2012
Recall Number Z-2590-2010
Recall Event ID 55173
Premarket Notification
510(K) Number
K060256 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software version: 4.9.01 The UniCel 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 Software Part Number: A84500, A86646; Software version: 4.9.01; Serial Number <2760
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
200 S Kraemer Blvd
Brea, California 92821-6208
Consumer Instructions No consumer action necessary
For Additional Information Contact Clair K. O'Donovan
714-993-5321
Manufacturer Reason
for Recall
Beckman Coulter is initiating a recall on their UniCel DxC Clinical Systems (880i, 860i,680i and 660i Systems with serial number <2760 that have software version 4.9.01 installed and have the VME Motorola ICS board) because they may exhibit issues with stat sample rack loading, causing a possible delay in results.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Beckman Coulter sent an URGENT: FIELD SAFETY NOTICE letter, dated March 25, 2010, to all customers. The letter identified the affected product, the problem, and the actions customers take. Customers were instructed to: if the UniCel DxC system serial number was less than 2760 the customer should contact their local representative to arrange for an upgrade to software version 4.9 build 02. Complete and return the enclosed response form within 10 days of the notice. Share the information with their laboratory staff and retain the notification as part of the Quality System documentation. If affected products were forwarded to another laboratory, provide a copy of the notification letter to them. Customers may contact the Customer Support Center (Hotline) at 1-800-854-3633. For questions or comments please contact the firm at (714) 961-3634.
Quantity in Commerce 22
Distribution Class II Recall - USA, including the states of CA, IN, GA, NC, NY, OH, SC, and WI
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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