BEUDAMED
    FDA Recall Open, Classified

    VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922

    Recall: Z-1112-2022 · Initiated March 25, 2022

    Recall

    Recall Number
    Z-1112-2022
    Event Number
    90047
    Firm
    Ortho-Clinical Diagnostics, Inc
    FEI Number
    2250051
    Product Code
    CGJ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    March 25, 2022
    Address
    1001 Us Highway 202, Raritan, NJ, 08869-1424

    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.

    Action

    Ortho CLinical Diagnostics issued "URGENT PRODUCT CORRECTION NOTIFICATION" dated 3/25/22 to consignees who had been shipped VITROS FSH, LH or Prol in the previous 18 months were notified (CL2022-069) of the issue and instructed as follows: -Run daily low-level QC in duplicate to confirm acceptable performance. -If their laboratory is experiencing low end imprecision with VITROS FSH, LH or Prol Reagent, follow one of the suggested testing algorithms as described in the enclosure. o Note: If their laboratory is not experiencing low end imprecision, continue testing patient samples as usual (single replicate). -Until further notice, all future lots of the products will also be affected. -On the enclosed Credit Form, track the additional quantities of VITROS FSH, LH and/or Prol tests used due to the testing protocol. Periodically submit the form to Ortho. Ortho will credit their account. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.

    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