BEUDAMED
    FDA Enforcement Class III Terminated

    VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.

    Recall: Z-1707-2015 · Reported June 10, 2015

    Enforcement

    Recall Number
    Z-1707-2015
    Event ID
    71176
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    ORTHO-CLINICAL DIAGNOSTICS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2015
    Initiation Date
    May 6, 2015
    Classification Date
    June 4, 2015
    Termination Date
    September 13, 2017
    Address
    FELINDRE MEADOWS, N/A, Bridgend, N/A, N/A, United Kingdom

    Description

    VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.

    Reason

    The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.

    Code Info

    Lot 3082, expiry date 7/27/2015

    Distribution

    Nationwide Distribution.

    Quantity

    Domestic: 898 units