BEUDAMED
    FDA Recall Open, Classified

    VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461

    Recall: Z-1676-2022 · Initiated July 19, 2022

    Recall

    Recall Number
    Z-1676-2022
    Event Number
    90681
    Firm
    Ortho-Clinical Diagnostics, Inc.
    FEI Number
    1000136573
    Product Code
    JJE
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 19, 2022
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461

    Reason

    Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.

    Action

    Ortho CLinical issued Urgent Medical Device Correction letter on 19 July 2022 to consignees who received a VITROS XT3400 or a VITROS XT7600 System notified via (CL2020-176) of the issue and instructed to: " If your VITROS XT 3400 and/or VITROS XT 7600 Systems require a system shutdown, routine Quality Control processing for MicroSlide assays must be performed per your laboratory procedure, prior to processing patient samples, to determine if the anomaly has occurred. " If QC results are outside your established ranges, Ortho recommends performing a second system shutdown and re-processing QC fluids for those assays that were outside your established ranges. If QC results are still outside established ranges following a second system shutdown, contact Ortho Care" Technical Solutions Center for guidance. " Ortho recommends using the same vial of QC fluids (where possible) throughout these steps to determine if the anomaly has occurred. Refer to the control storage and stability documentation for fluid stability guidelines once opened or reconstituted. " Post this notification by each VITROS XT 3400 and/or XT 7600 System until this issue is resolved. Ortho is currently investigating this issue; a follow-up communication will be released once our investigation is complete. " Complete the enclosed Confirmation of Receipt no later than July 26, 2022. If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Brazil, Canada L3R 4G5 , Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.

    Quantity

    1148 units