BEUDAMED
    FDA Enforcement Class III Terminated

    VITROS Immunodiagnostic Products TSH Reagent Pack

    Recall: Z-1322-2018 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1322-2018
    Event ID
    79508
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Clinical Diagnostic Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    April 18, 2018
    Initiation Date
    January 11, 2018
    Classification Date
    April 11, 2018
    Termination Date
    September 8, 2020
    Address
    601 Lee Rd Ny, Rochester, NY, 14652-0001, United States

    Description

    VITROS Immunodiagnostic Products TSH Reagent Pack

    Reason

    VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. These Calibrator Level 2 responses cause a higher than expected frequency of customer generated calibration curves to fall outside of the calibration quality parameter measuring the gradient of the Customer Calibration Curve between Calibrator Level 2 and Calibrator Level 3.

    Code Info

    Lot 5470, expiry date: 24-May-2018 Lot 5430, expiry date: 01-Mar-2018 (not distributed in the US.) Lot 5178 was also affected by this issue, expired on 31-Mar-2017,

    Distribution

    Distributors were notified via letter. Lot 5430 was not distributed in the US. Lot 5178 was also affected by this issue, but this lot expired on 31-Mar-2017 so Ortho took no action on this lot.

    Quantity

    Lot #5470 (US=8570/OUS=537); Lot #5430 (US=0/OUS=9135); Lot #5178 (US=5178/OUS=4396)