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U.S. Department of Health and Human Services

Class 2 Device Recall UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems

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  Class 2 Device Recall UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems see related information
Date Initiated by Firm May 07, 2009
Date Posted July 11, 2011
Recall Status1 Terminated 3 on May 07, 2012
Recall Number Z-2771-2011
Recall Event ID 55164
510(K)Number K060256  
Product Classification Antibody Radioassay - Product Code LIG
Product UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems

The Unicel DxC Integrated Workstation takes samples loaded from a single point of entry through a UCTA (UniCel Closed Tube Aliquotter). The UCTA functions as the sample processing manager by aliquotting and routing samples to the DxC and the Dxl analyzers according to the programming requirements
Code Information N/A
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information Contact Nora Zerounian
714-961-3634
Manufacturer Reason
for Recall		 The recall was initiated after Beckman Coulter confirmed reports of inaccurate Access Intrinsic Factor Ab test results displayed on, or printed from, the UniCel Dxl portion of an integrated workstation listed above. The problem is limited to numerical Intrinsic Factor Ab results produced on integrated systems running UniCel Dxl system software version 4.0, 4.1, or 4.2. The DxC portion of your inte
FDA Determined
Cause 2		 Software design
Action Beckman Coulter, Inc. sent out an "Urgent: Product Corrective Action" letter dated May 19, 2009 to all affected customers. The letter explained the reason for recall and provided recommendations including: -System software currently under development will correct this problem, and will be made available soon. Until then, please refer to UniCel DxC reports, user interface information, and LIS transmissions, which contain accurate Access Intrinsic Factor Ab test results. -Refer to the UniCel DxC system documentation for information on displaying and printing results from the DxC portion of an integrated workstation, or from your laboratory information system (LIS) -Past results for these assays only need to be reviewed if they were reported from the Dxl portion of an integrated workstation -Complete and return the enclosed response form For additional information please contact the Customer Technical Support at 1-800-854-3633, or your local Beckman Coulter representative.
Quantity in Commerce 5 units
Distribution Worldwide Distribution: (USA) Nationwide including KY; and the country of Canada.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = LIG and Original Applicant = BECKMAN COULTER, INC.
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