BEUDAMED
    FDA Enforcement Class II Ongoing

    VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922

    Recall: Z-1112-2022 · Reported May 25, 2022

    Enforcement

    Recall Number
    Z-1112-2022
    Event ID
    90047
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 25, 2022
    Initiation Date
    March 25, 2022
    Classification Date
    May 18, 2022
    Address
    1001 Us Highway 202, N/A, Raritan, NJ, 08869-1424, United States

    Description

    VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922

    Reason

    Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.

    Code Info

    Until further notice, future lots will also be affected. UDI: 10758750000302 Affected Lot Number/ Expiration Date: 3100 01-MAR-2022; 3111 25-MAR-2022; 3120 04-APR-2022; 3130 25-APR-2022; 3140 10-MAY-2022; 3145 10-MAY-2022; 3150 30-MAY-2022; 3160 09-JUN-2022; 3170 22-JUN-2022; 3180 02-AUG-2022; 3190 16-AUG-2022; 3200 06-SEP-2022; 3210 12-SEP-2022.

    Distribution

    Worldwide Distribution: US (Nationwide) OUS (Foreign): Australia Bermuda Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Netherlands Norway Portugal Russia Singapore Spain Sweden United Kingdom

    Quantity

    2502 total: 2154 US; 348 OUS