BEUDAMED
    FDA Enforcement Class II Terminated

    Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.

    Recall: Z-0701-2013 · Reported January 30, 2013

    Enforcement

    Recall Number
    Z-0701-2013
    Event ID
    63949
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 30, 2013
    Initiation Date
    September 18, 2012
    Classification Date
    January 22, 2013
    Termination Date
    February 4, 2013
    Address
    BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, 21152-0999, United States

    Description

    Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.

    Reason

    Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.

    Code Info

    Serial Numbers: MX0001 to MX0065 CM0001 to CM0105 NOTE: Serial numbers are assigned sequentially. The above ranges will include all sequential numbers in between the beginning and end points.

    Distribution

    USA including CT, FL, IL, KS, MD, MI, MO, NY, PA, RI, TX and WI. Internationally to Canada, Europe and Japan.

    Quantity

    86 Instruments