Events

Safety Alert for Analyzer for Enzymatic Immunoassays AIA

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Tosoh AIA || Tosoh Bioscience, Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1802-106
  • Event Number
    2012DM-0009432
  • Date
    2018-02-16
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=55
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer states that the photo switch (pi) in the previous analyzers may malfunction due to aging and deterioration of the current of the pi collector, this could lead to delays in the processing of the samples.

Device

Analyzer for Enzymatic Immunoassays AIA
  • Model / Serial
    AIA-900, AIA-900 with 9 bin sorter, AIA-900 with sorter
  • Product Description
    The AOS team of TOSIOH are automated analyzers (AIA900) and (AIA2000) of medium and high volume for high performance immunoassay for in-vitro diagnosis. It is designed for the assembly, processing and reading of Elisa tests. Sequential processes comprising an Elisa assay (sample pipetting, incubation, washing, reagent dispensing, stirring, optical density measurement and data deduction) are automatically performed according to specific test protocols.
  • Manufacturer
    Tosoh AIA || Tosoh Bioscience, Inc.

Manufacturer

Tosoh AIA || Tosoh Bioscience, Inc.
  • Manufacturer Parent Company (2017)
    Tosoh Corp.
  • Source
    NIDFSINVIMA