BEUDAMED
    FDA Recall Terminated

    Synchron Systems Hemoglobin A1c (HbA1c) Reagent

    Recall: Z-1101-04 · Initiated July 30, 2004

    Recall

    Recall Number
    Z-1101-04
    Event Number
    28961
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    JJY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 30, 2004
    Posted
    July 20, 2004
    Terminated
    August 30, 2004
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Synchron Systems Hemoglobin A1c (HbA1c) Reagent

    Reason

    Results of tests are biased low due to a vendor change in formulation not brought to the attention of the recalling firm.