BEUDAMED
    FDA Enforcement Class II Terminated

    Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Latex Reagent, DR0802, Lot 1301912. The responsible firm on the label is Oxoid Ltd.

    Recall: Z-0466-2015 · Reported December 3, 2014

    Enforcement

    Recall Number
    Z-0466-2015
    Event ID
    69566
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 3, 2014
    Initiation Date
    October 23, 2014
    Classification Date
    November 25, 2014
    Termination Date
    January 22, 2015
    Address
    12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

    Description

    Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Latex Reagent, DR0802, Lot 1301912. The responsible firm on the label is Oxoid Ltd.

    Reason

    A reagent within the test may return false negative results.

    Code Info

    DR0800M box lot 1316151, Exp. 30Sep2014

    Distribution

    Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT.

    Quantity

    59/50 test boxes