BEUDAMED
    FDA Recall Terminated

    UniCel DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel DxC Synchron Clinical Systems are fully automated, computercontrolled 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).

    Recall: Z-0123-2013 · Initiated September 3, 2012

    Recall

    Recall Number
    Z-0123-2013
    Event Number
    63143
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    September 3, 2012
    Posted
    October 24, 2012
    Terminated
    February 14, 2014
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    UniCel DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel DxC Synchron Clinical Systems are fully automated, computercontrolled 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).

    Reason

    Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment procedure cannot be performed on certain DxC configurations with v5.0.11 software installed. If the Shuttle to Barcode Reader becomes misaligned, the Operator will not be able to perform this alignment procedure on the DxC systems listed above. Software v5.0 .11 does not allow access to the Shuttle to Bar

    Action

    Beckman Coulter sent an Urgent Field Safety Notice dated August 30, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that their Beckman Coulter Service Representative would contac them to reinstall the software. Customers were asked to complete and return the enclosed Response Form. For questions customers were instructed to call their Customers Support Center on the Beckman Coulter website at www.BeckmanCoulter.com/CustomerSupport/SupportRequest. For questions regarding this recall call 714-993-5321.

    Distribution

    Worldwide Distribution - USA including TX and OH. Interntionally to China and Turkey

    Quantity

    7 units total (both US and International)