BEUDAMED
    FDA Enforcement Class II Ongoing

    STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612

    Recall: Z-1577-2023 · Reported May 17, 2023

    Enforcement

    Recall Number
    Z-1577-2023
    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 Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612

    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: 036074505898; Serial Numbers: 5061471 5061474 0000007405 CF70015885 CF70015886

    Distribution

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

    Quantity

    5 analyzers