BEUDAMED
    FDA Recall Terminated

    ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.

    Recall: Z-1448-06 · Initiated February 17, 2006

    Recall

    Recall Number
    Z-1448-06
    Event Number
    35880
    Firm
    Bayer Healthcare, LLC (Diagnostics Division)
    FEI Number
    2432235
    Product Code
    JGS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 17, 2006
    Posted
    August 29, 2006
    Terminated
    May 24, 2012
    Address
    511 Benedict Avenue, Tarrytown, NY, 10591-5097

    Description

    ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.

    Reason

    Low QC recovery observed on carbamazepine (CARB) results immediately following a Gentamicin (GENT) assay or a Digoxin (DIG) assay. When GENT or DIG precedes CARB, the CARB test result is artificially low (as much as -25%). PHNY was determined to also exhibit a similar carryover effect on CARB. All others were found not to produce the same reagent probe-based carryover effect.

    Action

    Bayer HealthCare LLC issued a Support Bulletin to all affected Bayer HealthCare LLC Branches on/about 2/17/06 in order to inform them of the issue and to provide them with instructions for this ''field correction''. Customer Bulletins were also issued to the Branches both in the United States and elsewhere for communication with the affected customers.

    Distribution

    Worldwide including USA and Puerto Rico.

    Quantity

    1138 for all products