BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- Ortho-Clinical Diagnostics High Wycombe UK. Note that one sales unit has 5 Reagent Packs contained within it. Each Reagent Pack can test for 100 samples (patient, Quality Control, etc.).

    Recall: Z-2671-2014 · Reported October 1, 2014

    Enforcement

    Recall Number
    Z-2671-2014
    Event ID
    68974
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ORTHO-CLINICAL DIAGNOSTICS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 1, 2014
    Initiation Date
    August 6, 2014
    Classification Date
    September 19, 2014
    Termination Date
    April 14, 2017
    Address
    FELINDRE MEADOWS, N/A, Bridgend, N/A, N/A, United Kingdom

    Description

    VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- Ortho-Clinical Diagnostics High Wycombe UK. Note that one sales unit has 5 Reagent Packs contained within it. Each Reagent Pack can test for 100 samples (patient, Quality Control, etc.).

    Reason

    VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expected VITROS Anti-HCV test results due to an approximate signal loss of up to 66.2% which can result in unexpected negative test results being obtained for reactive sample fluids (quality control and patient samples).

    Code Info

    Lot 9090 (exp. December 15, 2014)

    Distribution

    NY, NJ, CT, MA, PA, VA, MD, FL and GA

    Quantity

    463 sales units