BEUDAMED
    FDA Recall 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 · Initiated February 11, 2013

    Recall

    Recall Number
    Z-0927-2013
    Event Number
    64348
    Firm
    Innominata Dba Genbio
    FEI Number
    2027113
    Product Code
    LSR
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 11, 2013
    Posted
    March 8, 2013
    Terminated
    August 27, 2013
    Address
    15222 Avenue Of Science, Ste A, San Diego, CA, 92128-3422

    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.

    Action

    The firm, Innominata dba GenBio, sent an "Urgent Product Correction" letter dated February 11, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the listed questions to determine sites risk and take the appropriate actions. For questions regarding this issue, customers may contact Bio-Rad Technical Support at : 1-800-224-6723, option #2, and then option #3 for assistance.

    Distribution

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

    Quantity

    195