BEUDAMED
    FDA Recall 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 · Initiated May 6, 2015

    Recall

    Recall Number
    Z-1707-2015
    Event Number
    71176
    Firm
    ORTHO-CLINICAL DIAGNOSTICS FELINDRE MEADOWS Bridgend United Kingdom
    FEI Number
    3007111389
    Product Code
    CDP
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    May 6, 2015
    Posted
    June 4, 2015
    Terminated
    September 13, 2017

    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.

    Action

    On 5/06/2015, Customer Letter and Verification Form (Ref. CL15-095) were sent notifying the users of the issue and advised them of the required actions. The notification was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected product and advised them of the issue and the required actions. On 5/06/2015, Distributor Letter (Ref. DL15-095) was sent via US Postal Service Priority Mail and/or FedEx overnight courier to US Distributor consignees and instructed to notify their consignees of the issue and actions. For questions,questions, please contact Customer Technical Services at 1-800-421-3311 at any time.

    Distribution

    Nationwide Distribution.

    Quantity

    Domestic: 898 units