BEUDAMED
    FDA Recall Terminated

    BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48 Reaction Kit). For the rapid detection of methicillin resistant MRSA DNA in nasal specimen.

    Recall: Z-1963-2009 · Initiated November 11, 2008

    Recall

    Recall Number
    Z-1963-2009
    Event Number
    52107
    Firm
    BD Diagnostics (GeneOhm Sciences, Inc)
    FEI Number
    3004788834
    Product Code
    NQX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 11, 2008
    Posted
    September 10, 2009
    Terminated
    November 29, 2011
    Address
    6146 Nancy Ridge Dr, San Diego, CA, 92121

    Description

    BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48 Reaction Kit). For the rapid detection of methicillin resistant MRSA DNA in nasal specimen.

    Reason

    BD Diagnostics GeneOhm (BDDG) has determined that the Cepheid SmartCycler reaction tubes packaged in the BD GeneOhm MRSA test kits identified above may be defective.

    Action

    BD Diagnostics GeneOhm began contacting consignees by phone November 17, 2008 followed by a letter dated November 21, 2008 instructing discontinued use of the affected lots. Consignees were also asked to complete and return the enclosed Field Action Verification form. To arrange for product replacement or for further information, contact BD Diagnostics Technical Service at 1-888-436-3646 extension 2.

    Distribution

    Worldwide Distribution -- US (CA, IL, IN, KT, MD, ME, MN, MO, MT, NC, NJ, NY, OK, PA, TN, TX, UT, VA, and WI), Belgium and Japan.

    Quantity

    114 kits