BEUDAMED
    FDA Enforcement Class III Terminated

    VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The VIDAS NTproBNP (PBNP) test is used as an aid in the diagnosis of suspected congestive heart failure.

    Recall: Z-2779-2016 · Reported September 21, 2016

    Enforcement

    Recall Number
    Z-2779-2016
    Event ID
    73989
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomerieux France Chemin De L'Or
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 21, 2016
    Initiation Date
    April 15, 2016
    Classification Date
    September 9, 2016
    Termination Date
    July 21, 2017
    Address
    Chemin De L'Orme, N/A, Marcy L'Etoile, N/A, N/A, France

    Description

    VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The VIDAS NTproBNP (PBNP) test is used as an aid in the diagnosis of suspected congestive heart failure.

    Reason

    Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.

    Code Info

    Reference number: 30449-01, Lot #1004474560.

    Distribution

    US Nationwide Distribution in the states of: AL, AZ, CA, FL, GA, IA, KS, KY, MA, MI, MN, NC, NE, NJ, NY, OH, SC, TX, VA and WV.

    Quantity

    229 kits