BEUDAMED
    FDA Recall Terminated

    Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.

    Recall: Z-1031-03 · Initiated November 9, 2001

    Recall

    Recall Number
    Z-1031-03
    Event Number
    26516
    Firm
    Zeus Scientific Inc
    FEI Number
    2242436
    Product Code
    DHR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 9, 2001
    Posted
    July 19, 2003
    Terminated
    October 3, 2006
    Address
    200 Evans Way, Branchburg, NJ, 08876

    Description

    Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.

    Reason

    Calibrator C not meeting its optical density specification.

    Action

    Customers were notified of the recall via DHL on 11/9/2001. Customers were instructed to return or destroy product.

    Distribution

    The Sigma product was shipped to Sigma directly. The Zeus product was shipped to customers nationwide via DHL. Zeus customers consists of hospitals, and clinical laboratories.

    Quantity

    505