BEUDAMED
    FDA Recall Terminated

    DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 Northwestern Avenue, Stillwater, MN 55082. Made in the United Kingdom.

    Recall: Z-0927-05 · Initiated November 1, 2004

    Recall

    Recall Number
    Z-0927-05
    Event Number
    30950
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    MID
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 1, 2004
    Posted
    June 25, 2005
    Terminated
    July 22, 2006
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 Northwestern Avenue, Stillwater, MN 55082. Made in the United Kingdom.

    Reason

    DiaSorin Anti-Cardiolipin IgA Kit, catalog no. 7800, positive control was on the low limit of the acceptable range (16-35 U/mL).

    Action

    Customers were notifed of the product and the problem and were advised to destroy any remaining inventory and replacements were offered.

    Distribution

    NY, KS, GA & MT

    Quantity

    49