BEUDAMED
    FDA Recall Terminated

    Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma

    Recall: Z-0844-2019 · Initiated November 29, 2018

    Recall

    Recall Number
    Z-0844-2019
    Event Number
    81767
    Firm
    Ortho Clinical Diagnostics Inc
    FEI Number
    2250051
    Product Code
    JIS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 29, 2018
    Terminated
    February 6, 2024
    Address
    1001 US Highway 202, Raritan, NJ, 08869-1424

    Description

    Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma

    Reason

    A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.

    Action

    On November 29, 2018, the firm sent a customer letter all affected customers. All consignees were notified of the issue and informed of revised instructions for VITROS Myoglobin Calibrators: - Reconstitute the calibrators using 1.0 mL distilled water, as per current instructions. - Allow reconstituted calibrator vials to stand at room temperature for 2 hours and then proceed with calibration within 2 hours (4 hours total) - Discard reconstituted calibrators after 4 hours. - Acknowledge the information contained in this notification by completing and submitting the Confirmation of Receipt form no later than December 14, 2018. - Post this notification by each VITROS System at your facility that processes this assay or with the user documentation. - Please forward this notification if the product was distributed outside of your facility. If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.

    Distribution

    Distributed nationwide domestically. Foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and the Netherlands.

    Quantity

    4030