BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0557-2014 · Initiated October 25, 2013

    Recall

    Recall Number
    Z-0557-2014
    Event Number
    66900
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    LOM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 25, 2013
    Posted
    December 20, 2013
    Terminated
    May 18, 2018
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    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.

    Action

    On October 25, 2013, Ortho Clinical Diagnostics issued product correction notifications to their US customers via US Postal Service Priority Mail and email notices to their foreign affiliates informing them of the recall. Ortho Clinical Diagnostics advised their customers to review previously reported results between > 12 and <30 mIU/mL and consult the Laboratory Medical Director. Customers were instructed to utilize alternative methods for anti-HBs testing. Customers are advised to seek alternative methods for anti-HBs testing. For additional information, please contact the OCD Customer Technical Service representative at 1-800-421-3311.

    Distribution

    Nationwide distribution - all states.

    Quantity

    1,920 kits