BEUDAMED
    FDA Recall Terminated

    TosohAutomated 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 · Initiated June 11, 2017

    Recall

    Recall Number
    Z-0491-2018
    Event Number
    78776
    Firm
    Tosoh Bioscience Inc
    FEI Number
    3005529799
    Product Code
    KHO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 11, 2017
    Terminated
    December 31, 2019
    Address
    3600 Gantz Rd, Grove City, OH, 43123-1895

    Description

    TosohAutomated 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.

    Action

    Customers were sent a recall notification by email on July 11, 2017 informing them that their local Field Service Engineer would contact them to make arrangements to proactively replace the affected parts. Follow up notifications will be by Federal Express with verification of delivery.

    Distribution

    Worldwide Distribution - U.S. Nationwide - Latin America

    Quantity

    565 total devices U.S.