BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported April 26, 2023

    Enforcement

    Recall Number
    Z-1396-2023
    Event ID
    92017
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 26, 2023
    Initiation Date
    March 9, 2023
    Classification Date
    April 18, 2023
    Address
    1001 Us Highway 202, N/A, Raritan, NJ, 08869-1424, United States

    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

    Code Info

    UDI: 10758750034581 Lot # /Expiration Date: 0230 22-Feb-2023; 0240 22-Mar-2023; 0250 26-Apr-2023.

    Distribution

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

    Quantity

    256 units