BEUDAMED
    FDA Enforcement Class III Terminated

    VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.

    Recall: Z-2580-2016 · Reported August 24, 2016

    Enforcement

    Recall Number
    Z-2580-2016
    Event ID
    74828
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    ORTHO-CLINICAL DIAGNOSTICS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 24, 2016
    Initiation Date
    July 28, 2016
    Classification Date
    August 17, 2016
    Termination Date
    June 11, 2018
    Address
    FELINDRE MEADOWS, N/A, Bridgend, N/A, N/A, United Kingdom

    Description

    VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.

    Reason

    A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected frequency of customer calibration curves falling outside of the calibration quality parameters and therefore unusable to process samples. Customers using VITROS TSH Lot 5040 will potentially experience an unexpected increase in the unsuccessful calibrations potentially causing a delay in testing and reporting results for VITROS TSH.

    Code Info

    Lot 5040 (Expiry date 19 Dec 2016)

    Distribution

    Worldwide Distribution - US to VA, WV, GA, TN, KY, MN, SD, AR, OK and Internationally to Canada

    Quantity

    Domestic: 2883, Foreign: 1261