BEUDAMED
    FDA Recall Open, Classified

    STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026

    Recall: Z-1575-2023 · Initiated March 22, 2023

    Recall

    Recall Number
    Z-1575-2023
    Event Number
    92007
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    JPA
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    March 22, 2023
    Posted
    May 10, 2023
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    Description

    STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026

    Reason

    An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).

    Action

    Customers were contacted via telephone and an URGENT: MEDICAL DEVICE CORRECTION notification letter beginning 3/22/23. Actions: Stago downgraded your firmware to the previous firmware version as a precaution. Your downgrade has already occurred. Consequently, the risk of this bug only existed during the time period shown above (i.e. from new firmware installation date to the downgrade date). As patient results are interpreted in association with other biological tests, we leave the decision to review previous patient results based on the complete clinical context to your discretion. Our Customer Service team is available to help you carry out your impact analysis. For additional information, please contact your Stago Hotline at 1-800-725-0607.

    Distribution

    US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.

    Quantity

    6 analyzers