BEUDAMED
    FDA Recall Terminated

    Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 576 Tests, Catalog No. 576DS, Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA The Bio-Rad Autoimmune EIA Anti-dsDNA Test is a qualitative enzyme immunoassay (EIA) intended to screen for the presence of dsDNA antibodies in human serum as an aid in the diagnosis of systemic lupus erythematosus (SLE). For In Vitro Diagnostic Use.

    Recall: Z-1648-2011 · Initiated March 2, 2010

    Recall

    Recall Number
    Z-1648-2011
    Event Number
    56044
    Firm
    Bio-Rad Laboratories Inc
    FEI Number
    2915274
    Product Code
    LRM
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 2, 2010
    Posted
    March 14, 2011
    Terminated
    March 15, 2011
    Address
    4000 Alfred Nobel Dr, Hercules, CA, 94547-1803

    Description

    Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 576 Tests, Catalog No. 576DS, Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA The Bio-Rad Autoimmune EIA Anti-dsDNA Test is a qualitative enzyme immunoassay (EIA) intended to screen for the presence of dsDNA antibodies in human serum as an aid in the diagnosis of systemic lupus erythematosus (SLE). For In Vitro Diagnostic Use.

    Reason

    The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits.

    Action

    The firm, Bio-Rad, sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated March 2, 2010 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory and quarantine the affected kit lots; discard all affected product in accordance with all local, state and federal disposal procedures; complete and return the enclosed MEDICAL DEVICE RECALL RESPONSE FORM via fax to: (510) 741-3954, attn: Bio-Rad CSD Regulatory Affairs Department, and to please re-evaluate all positive patient samples and retest if necessary. If you have any questions, contact Bio-Rad CSD Regulatory Affairs Department at 510-724-7000.

    Distribution

    Worldwide distribution: USA and countries including: Canada, Carribean, Chile, France, Germany, Hong Kong, India, Italy, Japan, New Zealand, Panama, Singapore, South Korea and United Kingdom.