BEUDAMED
    FDA Recall Terminated

    DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of androstenedione levels in serum. Catalog No. CA-1725. Lot # 04164. DiaSorin Stillwater, Minnesota 55082-0285, U.S.A.

    Recall: Z-0704-05 · Initiated May 25, 2004

    Recall

    Recall Number
    Z-0704-05
    Event Number
    30932
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    CIZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 25, 2004
    Posted
    April 13, 2005
    Terminated
    July 22, 2006
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of androstenedione levels in serum. Catalog No. CA-1725. Lot # 04164. DiaSorin Stillwater, Minnesota 55082-0285, U.S.A.

    Reason

    Standards contained in the GammaCoat Androstenedione RIA Kit appeared yellowish in color and were gelatinous upon reconstitution. The assay validation criteria failed when the gelatinous standards were used.

    Action

    Customers were sent notification letters informing them of the product and problem and recommended the destruction of any remaining inventory. Letter also requested the completion and return of the lower portion of the letter.

    Distribution

    Massachusetts, Saudi Arabia, Sweden, Germany, Spain, Belgium, Italy, Camada. Australia, Portugal, Hungary, Israel,

    Quantity

    70 kits