BEUDAMED
    FDA Recall Terminated

    VITROS Immunodiagnostic Products TSH Reagent Pack

    Recall: Z-1322-2018 · Initiated January 11, 2018

    Recall

    Recall Number
    Z-1322-2018
    Event Number
    79508
    Firm
    Clinical Diagnostic Systems
    FEI Number
    3003939841
    Product Code
    JLW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 11, 2018
    Posted
    April 10, 2018
    Terminated
    September 8, 2020
    Address
    601 Lee Rd, Ny Rochester, NY, 14652-0001

    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.

    Action

    Distributors instructed to disgard remaining inventory, complete Confirmation of Receipt form, and firm promised to replace product. Distributors instructed to send letter to customers.

    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)