BEUDAMED
    FDA Recall Open, Classified

    VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)

    Recall: Z-1229-2024 · Initiated January 26, 2024

    Recall

    Recall Number
    Z-1229-2024
    Event Number
    93927
    Firm
    Ortho-Clinical Diagnostics, Inc.
    FEI Number
    1000136573
    Product Code
    JJE
    Status
    Open, Classified
    Root Cause
    Software Design Change
    Initiated
    January 26, 2024
    Posted
    March 1, 2024
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)

    Reason

    A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.

    Action

    On January 26, 2024, the firm issued a customer letter to all customers who have V3.8.0 or V3.8.1 installed on their VITROS Analyzer. Customers were informed of the issue and instructed to follow the instructions when using the VITROS System onboard QC package to use the configurable Westgard Rules. The software will be updated to mitigate this issue within the VITROS Software QC feature. The estimated availability is 2Q2024. If you have further questions, please contact Global Services Organization at 1-800-421-3311.

    Distribution

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

    Quantity

    9 US; 66 OUS