BEUDAMED
    FDA Enforcement Class II Terminated

    ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.

    Recall: Z-0927-2013 · Reported March 20, 2013

    Enforcement

    Recall Number
    Z-0927-2013
    Event ID
    64348
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Innominata Dba Genbio
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 20, 2013
    Initiation Date
    February 11, 2013
    Classification Date
    March 8, 2013
    Termination Date
    August 27, 2013
    Address
    15222 Avenue Of Science Ste A, N/A, San Diego, CA, 92128-3422, United States

    Description

    ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.

    Reason

    Multiple incidents of low-reacting assay plates.

    Code Info

    Lot #120960 (121003. 121058,121002), ; Exp./Cad/Verw/bis: 2013-09; Catalog#802-3011; 25271, 25272, 25273; Label P/N 522-0040, 522-0037, 522-0011

    Distribution

    Nationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI.

    Quantity

    195