BEUDAMED
    FDA Recall Terminated

    ETI-MP IgM Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of specific IgM antibodies to Mycoplasma pneumoniae in human serum. Test kit for 192 determinations. Catalog No. 4700. For In Vitro Diagnostic use. manufactured for DiaSorin Inc., 1950 Northwestern Avenue P.O. Box 285, Stillwater, MN 55082-0285

    Recall: Z-0633-05 · Initiated October 20, 2004

    Recall

    Recall Number
    Z-0633-05
    Event Number
    30930
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    LAZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 20, 2004
    Posted
    March 18, 2005
    Terminated
    July 22, 2006
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    ETI-MP IgM Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of specific IgM antibodies to Mycoplasma pneumoniae in human serum. Test kit for 192 determinations. Catalog No. 4700. For In Vitro Diagnostic use. manufactured for DiaSorin Inc., 1950 Northwestern Avenue P.O. Box 285, Stillwater, MN 55082-0285

    Reason

    2 lots of ETI-MP IgM assay kits showed a decline in Optical Density (OD) reading of the positive control and calibrators, P10 and P50. The decline in OD of the positive control and calibrators (P10 & P50) would cause the assay validation criteria to fail.

    Action

    Customers were sent notification letters. Recommended to detroy the remaining kits and requested a form be returned which indicates the number of kits destroyed so they can arrange replacement.

    Distribution

    MA, OH & IL