BEUDAMED
    FDA Enforcement Class II Terminated

    Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series.

    Recall: Z-0491-2018 · Reported February 7, 2018

    Enforcement

    Recall Number
    Z-0491-2018
    Event ID
    78776
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tosoh Bioscience Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 7, 2018
    Initiation Date
    June 11, 2017
    Classification Date
    January 30, 2018
    Termination Date
    December 31, 2019
    Address
    3600 Gantz Rd, Grove City, OH, 43123-1895, United States

    Description

    Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series.

    Reason

    This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential malfunction has been attributed to aging and premature deterioration of the Pl collector current.

    Code Info

    All Photo Interrupter sensors that are current in AIA-900 analyzers with serial number(S/N) 10000103 to S/N 11147003.

    Distribution

    Worldwide Distribution - U.S. Nationwide - Latin America

    Quantity

    565 total devices U.S.