BEUDAMED
    FDA Enforcement Class II Terminated

    AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series.

    Recall: Z-0475-2019 · Reported November 28, 2018

    Enforcement

    Recall Number
    Z-0475-2019
    Event ID
    81194
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tosoh Bioscience Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 28, 2018
    Initiation Date
    September 28, 2018
    Classification Date
    November 16, 2018
    Termination Date
    May 29, 2020
    Address
    3600 Gantz Rd, N/A, Grove City, OH, 43123-1895, United States

    Description

    AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series.

    Reason

    There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during the washing step. Incomplete washing of the sample may result in falsely elevated test results for the sandwich assays and falsely decreased test results for the competitive binding assays. Insufficient washing is detectable through review of the calibration data and QC trending. For example, if incomplete washing occurs, the reported values for the zero- calibration rate will be above the acceptance range. The calibration value may shift and the instrument will not calibrate successfully. If this issue occurs, there may be a delay in testing and reporting patient test results. There have been no user or patient injuries reported related to this issue.

    Code Info

    Serial Nos. 10038409, 10038509, 10048009R, 10058011, 10069507, 80018112, 80039511

    Distribution

    US Nationwide distribution in the states of Florida, Kentucky, Maryland, Ohio, Pennsylvania, and Texas.

    Quantity

    7