BEUDAMED
    FDA Enforcement Class II Completed

    AggreGuide A-100 Instrument

    Recall: Z-1639-2022 · Reported September 7, 2022

    Enforcement

    Recall Number
    Z-1639-2022
    Event ID
    90588
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Aggredyne, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 7, 2022
    Initiation Date
    July 23, 2019
    Classification Date
    August 26, 2022
    Address
    10530 Rockley Rd Ste 150, Houston, TX, 77099-3574, United States

    Description

    AggreGuide A-100 Instrument

    Reason

    The firm identified a software design issue where the improper shut down of the instrument resulted in speeds.csv file contents of the software version 5.1 being erased. Due to this issue, the target RPM for the assay is 0 and the motor output required to achieve this RPM is also 0. Therefore, when the assay is run, the software applies 0 Volts to the motor and performs a 0 RPM assay. Because of this, there is no mixing of the blood with agonist and no moving of aggregates happens in front of the optical detectors. The resulting PAI is 0 and the result is displayed as Low.

    Code Info

    UDI-DI: 00856893004065; Software Versions 5.1 or 5.2; Serial Numbers Between xx0001 and xx0160

    Distribution

    International distribution to the country of South Korea.

    Quantity

    47