BEUDAMED
    FDA Recall Terminated

    Beckman Coulter Access Hybritech free PSA Calibrators, REF 37215. The Access Hybritech free PSA assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (PSA) in human serum using the Access Immunoassay System.

    Recall: Z-2220-2009 · Initiated January 8, 2008

    Recall

    Recall Number
    Z-2220-2009
    Event Number
    48960
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    MTG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 8, 2008
    Posted
    September 16, 2009
    Terminated
    November 29, 2011
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Beckman Coulter Access Hybritech free PSA Calibrators, REF 37215. The Access Hybritech free PSA assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (PSA) in human serum using the Access Immunoassay System.

    Reason

    Beckman Coulter incorrectly shipped Access Hybritech free PSA calibrators containing dual calibration cards (Hybritech and WHO) to your lab. The WHO calibration for free PSA is marketed without a PMA.

    Action

    Beckman Coulter contacted customers by phone beginning January 11, 2009 and sending a Product Corrective Action letter informing them to discontinue use and discard the referenced product immediately. For further information, contact Customer Technical Support at 1-800-854-3633 or contact your local Beckman Coulter Representative.

    Distribution

    Nationwide Distribution -- OH, CA, TX, OR, MD, MO, FL and PA.

    Quantity

    22 Kits