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Class 2 Device Recall Beckman Coulter UniCel DxC 880i, 860i, and 600i Systems |
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Date Initiated by Firm |
February 25, 2010 |
Date Posted |
September 30, 2010 |
Recall Status1 |
Terminated 3 on July 02, 2012 |
Recall Number |
Z-2590-2010 |
Recall Event ID |
55173 |
510(K)Number |
K060256
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Product Classification |
Analyzer chemistry (photometric, discrete), for clinical use - Product Code JJE
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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 CA 92821-6208
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For Additional Information Contact |
Clair K. O'Donovan 714-993-5321
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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.
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FDA Determined Cause 2 |
Other |
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
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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.
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510(K) Database |
510(K)s with Product Code = JJE and Original Applicant = BECKMAN COULTER, INC.
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