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
    I1605-199
  • Event Number
    2012DM-0009432
  • Date
    2016-05-10
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=142
  • 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 has identified that the accumulation of data in the bases of the referenced device could slow down and present the code of error 2032 "there is no answer to the question" causing problems in the coincidence of results, which could lead to the occurrence of potentially adverse events about patients and loss of results on the front.

Device

Analyzer for Enzymatic Immunoassays AIA
  • Model / Serial
    AIA-1800ST, AFP-1800LA, AIA-2000ST and AFP-200LA
  • Product Description
    The TOSOH AIA equipment is an automated analyzer (AIA900) and (AIA2000) of medium and high volume for high performance parainmunoassay for in-vitro diagnostics. It is designed for the assembly, processing and reading of elisa assays. Sequential processes that comprise 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