BEUDAMED
    FDA Recall Terminated

    Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.

    Recall: Z-1474-2014 · Initiated March 17, 2014

    Recall

    Recall Number
    Z-1474-2014
    Event Number
    67777
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    LIB
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 17, 2014
    Posted
    April 18, 2014
    Terminated
    December 11, 2014
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.

    Reason

    A reagent contained within the product may return false negative results.

    Action

    The recalling firm initiated a recall by issuing letters dated 3/17/14 via regular mail to their customers.

    Distribution

    Distribution was made to CA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, and VT. There was no foreign/military/government distribution.

    Quantity

    2/50-test boxes