BEUDAMED
    FDA Recall Terminated

    DiaSorin GammaCoat Androstenedione - [125I] RIA Kit Catalog No. CA-1725, DiaSorin Stillwater, Minnesota 55082-0285, U.S.A. Lot # 05144. for the quantitative determination of androstenedione levels in serum.

    Recall: Z-0634-05 · Initiated July 15, 2004

    Recall

    Recall Number
    Z-0634-05
    Event Number
    30937
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    CIZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 15, 2004
    Posted
    March 18, 2005
    Terminated
    July 22, 2006
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    DiaSorin GammaCoat Androstenedione - [125I] RIA Kit Catalog No. CA-1725, DiaSorin Stillwater, Minnesota 55082-0285, U.S.A. Lot # 05144. for the quantitative determination of androstenedione levels in serum.

    Reason

    Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution.

    Action

    Customers were sent a customer notification letter identifying the product and the problem and requesting a response identifying the number of replacement kits needed.

    Distribution

    MN, MA, KY, Saudi Arabia, Jordan, Sweden, Germany, Spain, Belgium, Italy, Canada, Australia, Portugal, Hungary, Switzerland & Israel

    Quantity

    163 Kits (lot 05144) 95 Kits (06114B)