BEUDAMED
    FDA Recall Terminated

    VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.

    Recall: Z-2152-2014 · Initiated October 14, 2013

    Recall

    Recall Number
    Z-2152-2014
    Event Number
    68749
    Firm
    BioMerieux SA Chemin De L'Orme Marcy L'Etoile France
    FEI Number
    1000611339
    Product Code
    MTF
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    October 14, 2013
    Posted
    August 6, 2014
    Terminated
    August 28, 2017

    Description

    VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.

    Reason

    Product is not approved or authorized for distribution in the US.

    Action

    A letter was issued on October 14, 2013 to consignees requesting the consignee to check their stock and destroy all kits of the VIDAS TPSA ref. 30428. The letter also requested that the consignee notify their accounts of the recall. An acknowledgment form was also included with the letter which is to be returned to BioMerieux.

    Distribution

    FL, LA, MI, MS, NV, OH, OK, TN, TX

    Quantity

    1902