BEUDAMED
    FDA Enforcement Class II Terminated

    AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.

    Recall: Z-0602-2019 · Reported December 19, 2018

    Enforcement

    Recall Number
    Z-0602-2019
    Event ID
    81172
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tosoh Bioscience Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 19, 2018
    Initiation Date
    September 28, 2017
    Classification Date
    December 13, 2018
    Termination Date
    December 8, 2020
    Address
    3600 Gantz Rd, N/A, Grove City, OH, 43123-1895, United States

    Description

    AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.

    Reason

    The firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing home detection sensor relay harness on your AIA-900 Analyzer. It is possible that the harnesses could rub against the Plarail chain during operation and result in premature wear. If observed, this issue will cause the following system error to be reported D.lane Mix home overrun error [4093] . If observed, this issue will cause the AIA-900 Analyzer not to function and the D.lane Mix home overrun error [4093] will be reported by the system. Replacement of the motor drive harness and mixing home detection sensor relay harness will mitigate the potential for premature wear and effectively prevent this issue from causing the system error. If the sensor relay harness fails, the AIA-900 analyzer will cease to function and will be unavailable for use. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh is aware of two complaints associated with the unexpected wearing of the harness. There have been no user or patient injuries reported that are related to this device malfunction.

    Code Info

    All active analyzer serial numbers

    Distribution

    Nationwide distribution. Foreign distribution to Chile, Colombia, Ecuador, Guatemala, Honduras, Panama, Peru, Puerto Rico, Uruguay, and Venezuela.

    Quantity

    258