BEUDAMED
    FDA Recall Terminated

    Varcella Zoster ELISA Kit for the detection of IgG antibodies to varicella zoster virus in human serum, Catalog No.: 4620. DiaSorin Stillwater, Minnesota 55082-0285

    Recall: Z-0572-05 · Initiated September 10, 2003

    Recall

    Recall Number
    Z-0572-05
    Event Number
    30891
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    LFY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 10, 2003
    Posted
    March 8, 2005
    Terminated
    July 22, 2006
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    Varcella Zoster ELISA Kit for the detection of IgG antibodies to varicella zoster virus in human serum, Catalog No.: 4620. DiaSorin Stillwater, Minnesota 55082-0285

    Reason

    Varicella Zoster ELISA kit assay was producing invalid runs on the ETI-Max 3000 automated microtiter plate instrument and/or false negative results.

    Action

    Kit was initially placed on hold. Later Kit was discontinued and an alternate which would run correctly on the ETI-Max 3000 automated platform was found and offered to customers.

    Distribution

    AL, CA, IL, KS, MA, MI & NJ

    Quantity

    99 kits