BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1575-2023 · Reported May 17, 2023

    Enforcement

    Recall Number
    Z-1575-2023
    Event ID
    92007
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Diagnostica Stago, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 17, 2023
    Initiation Date
    March 22, 2023
    Classification Date
    May 10, 2023
    Address
    5 Century Dr, N/A, Parsippany, NJ, 07054-4607, United States

    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).

    Code Info

    UDI-DI: 036074505901; Serial Numbers: CP86010393 DB68093186 CP87010814 CP86070669 CP86090743 CP86090744

    Distribution

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

    Quantity

    6 analyzers