BEUDAMED
    FDA Recall Terminated

    IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosis of infectious Mononucleosis.

    Recall: Z-1148-2013 · Initiated February 26, 2013

    Recall

    Recall Number
    Z-1148-2013
    Event Number
    64790
    Firm
    Alere San Diego, Inc.
    FEI Number
    1000125596
    Product Code
    KTN
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    February 26, 2013
    Posted
    April 18, 2013
    Terminated
    August 29, 2013
    Address
    9975 Summers Ridge Rd, San Diego, CA, 92121-2997

    Description

    IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosis of infectious Mononucleosis.

    Reason

    Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.

    Action

    Alere sent an Urgent Medical Device Recall letter dated February 26, 2013, to all affected customers. The letter informs the customers of the problems identified and the actions to be taken. Customers with unused product remaining are instructed to immediately discard it. Investigations of customer complaints indicate that the positive control included with this lot may produce false negative results. Customers are instructed to return the attached Verification form. Customers that have consumed all product are instructed to indicate zero under "Quantity Discarded" and complete and fax back the form. Replacement product will be provided for any unused portion of the affected lot based on completion and return of the attached Verification Form. Customers with any questions are instructed to contact Alere Technical Services at (866) 216-0094 or by email at [email protected]. For questions regarding this recall call 858-805-2000, ext 3015.

    Distribution

    Nationwide Distribution including TN, WA, UT, KS, KY, MN, GA, MA, PA, NY, VT, and the Dist. of Columbia

    Quantity

    78 kits