BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs

    Recall: Z-0557-2014 · Reported January 1, 2014

    Enforcement

    Recall Number
    Z-0557-2014
    Event ID
    66900
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2014
    Initiation Date
    October 25, 2013
    Classification Date
    December 20, 2013
    Termination Date
    May 18, 2018
    Address
    100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States

    Description

    VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs

    Reason

    Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive results.

    Code Info

    Product Code 1) 6801926, 2) 6801925, 3) 6802452 Lot numbers: 1) 6700, 2) 6731, 3) 6830 Expiry Dates: 1) 21 May 2013, 2) 24 July 2013, 3) 11 Sept 2013

    Distribution

    Nationwide distribution - all states.

    Quantity

    1,920 kits