BEUDAMED
    FDA Recall Terminated

    25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater, Minnesota 55082-0285, U.S.A.

    Recall: Z-1237-2007 · Initiated August 21, 2007

    Recall

    Recall Number
    Z-1237-2007
    Event Number
    39413
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    MRG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 21, 2007
    Posted
    September 20, 2007
    Terminated
    October 17, 2008
    Address
    1951 Northwestern Ave S P.O Box 285, Stillwater, MN, 55082-7536

    Description

    25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater, Minnesota 55082-0285, U.S.A.

    Reason

    25 Hydroxyvitamin D RIA kits may contain the incorrect lot of tracer.

    Action

    Consignees were notified by phone on 8/21/07 followed by a written notification by Fax or email. The letter described the product and problem and recommended to inspect the kits and to destroy all tracer vials of lot number 726023. They also requested the consignee to return the findings by fax or mail.

    Distribution

    Worldwide, including USA, CANADA, BRAZIL, INDIA, QATAR, SWEDEN, URUGUAY, ARGENTINA, and JORDAN.

    Quantity

    117 kits