BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0701-2013 · Initiated September 18, 2012

    Recall

    Recall Number
    Z-0701-2013
    Event Number
    63949
    Firm
    Becton Dickinson & Co. BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    NJR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 18, 2012
    Posted
    January 22, 2013
    Terminated
    February 4, 2013
    Address
    7 Loveton Circle, Sparks, MD, 21152-0999

    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.

    Action

    Becton Dickinson sent an Urgent Field Corrective Action letter September 18, 2012,by fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that BD Field Service Associates will contact them within 7-10 days of the notification to determine if their instrument is impacted. Customers were requested to return a response form indicating the serial number on their instrument. If customers needed further assistance they were instrycted ti contact BD Technical Services Department at 1-800-638-8663. For questions regarding this recall call 410-316-4054.

    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