BEUDAMED
    FDA Enforcement Class II Terminated

    Tosoh AIA-900 immunoassay Analyzer

    Recall: Z-0485-2019 · Reported November 28, 2018

    Enforcement

    Recall Number
    Z-0485-2019
    Event ID
    81219
    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 19, 2018
    Termination Date
    July 8, 2020
    Address
    3600 Gantz Rd, N/A, Grove City, OH, 43123-1895, United States

    Description

    Tosoh AIA-900 immunoassay Analyzer

    Reason

    A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the problem. This failure is mitigated by the hardware design. The consequence would be a slight delay in testing patient sample or reporting patient result.

    Code Info

    10313605 10503612 10634103

    Distribution

    Distributed to accounts in GA and NY.

    Quantity

    3