BEUDAMED
    FDA Recall Open, Classified

    VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code: 6199976

    Recall: Z-1396-2023 · Initiated March 9, 2023

    Recall

    Recall Number
    Z-1396-2023
    Event Number
    92017
    Firm
    Ortho-Clinical Diagnostics, Inc.
    FEI Number
    2250051
    Product Code
    QKO
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    March 9, 2023
    Posted
    April 18, 2023
    Address
    1001 Us Highway 202, Raritan, NJ, 08869-1424

    Description

    VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code: 6199976

    Reason

    Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results

    Action

    Ortho Clinical Diagnostics issued Important Product Correction Notification letter on 3/9/23. Letter states reason for recall, health risk and action to take: To calibrate all lots currently within expiring date of Anti-SARS-CoV-2 Total N, load ADD 6219 or higher on your VITROS System. " Complete the enclosed Confirmation of Receipt form no later than March 17, 2023. " Please forward this notification and ADD if the affected product was distributed outside of your facility. " If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Ortho Care" Technical Solutions Center. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.

    Distribution

    US Nationwide distribution in the states of AL, AZ, CA, GA, NY.

    Quantity

    256 units