BEUDAMED
    FDA Recall Terminated

    DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C

    Recall: Z-0658-05 · Initiated November 1, 2004

    Recall

    Recall Number
    Z-0658-05
    Event Number
    30953
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    LSE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 1, 2004
    Posted
    March 29, 2005
    Terminated
    July 22, 2006
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C

    Reason

    The DiaSorin ETI-EA-G kits contained the wrong microtiter plate. The plate provided in the kits was for a different product, the ProTrac II Tacrolimus kit.

    Action

    Customers were notified of the product and problem via telephone and instructed to check any remaining inventory and discard all incorrect plates. Replacement plates were offered.

    Distribution

    FL, TX & UT

    Quantity

    46