BEUDAMED
    FDA Recall Terminated

    Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High Positive Control, 1 Low Positive Control, 1 Substrate, 1 Stop Reagent. Labeled: Distributed by: Bio-Rad Laboratories-Redmond, WA 98052 For the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment to the patient's immunological response to rubella, and as a qualitative screening test to determine the immune status of individuals, including women of childbearing age.

    Recall: Z-0908-2010 · Initiated August 20, 2008

    Recall

    Recall Number
    Z-0908-2010
    Event Number
    49449
    Firm
    Bio-Rad Laboratories
    FEI Number
    3008272466
    Product Code
    LFX
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    August 20, 2008
    Posted
    March 2, 2010
    Terminated
    April 8, 2010
    Address
    6565 185th Ave NE, Redmond, WA, 98052-5039

    Description

    Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High Positive Control, 1 Low Positive Control, 1 Substrate, 1 Stop Reagent. Labeled: Distributed by: Bio-Rad Laboratories-Redmond, WA 98052 For the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment to the patient's immunological response to rubella, and as a qualitative screening test to determine the immune status of individuals, including women of childbearing age.

    Reason

    Elevated optical density (OD) values with the kit Negative Control.

    Action

    An "Urgent Product Correction" letter dated August 26, 2008 was sent via overnight carrier to all customers. The letter described the affected product, problem, and action to be taken by customer. The customers are to review their current inventory of the product for any remaining kits of the specified lot number. The customer is to complete the form and fax to the Technical Support department if replacement kits were needed. The remaining kits will be replaced once the form is completed and faxed. If you have any questions, please contact Technical Support at 1-800-224-6723, options 2 then 4.

    Distribution

    Nationwide distribution: NE, NY, FL, GA, MA, OR, WI, MN, MI, MS, NC, CA, MD, MO, IA, DC

    Quantity

    82 kits