BEUDAMED
    FDA Recall Terminated

    DiaSorin Analyte Specific Reagent

    Recall: Z-0706-05 · Initiated January 18, 2005

    Recall

    Recall Number
    Z-0706-05
    Event Number
    31095
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    DGK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 18, 2005
    Posted
    April 13, 2005
    Terminated
    July 22, 2006
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    DiaSorin Analyte Specific Reagent

    Reason

    Expiration date of 2005/1/6 stamped on vial label of Anti-Human igG, Fluorescein Conjugate is incorrect. Correct expiration date is 2006/1/6.

    Action

    Customers were notified of the incorrect expiration date and instructed to destroy the vials with the incorrect date and product replacement was offered.

    Distribution

    WA, MA, and Korea

    Quantity

    1