Events

Safety Alert for ARCHITECT FREE T4 REAGENT

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by ABBOTT IRELAND DIAGNOSTICS DIVISION || Imported by: ABBOTT LABORATORIES DE || COLOMBIA S.A..

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
    RDA1705-7
  • Event Number
    INVIMA 2016RD-0000041
  • Date
    2017-05-08
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=90
  • 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
    Abbott issues alert to report a change in the measurement interval of the architect free t4 test with references 7k65-29 and 7k65-39. recent data have determined that the measurement range of this trial is from 0.40 ng / dl to 5.00 ng / dl. the measurement range is defined as the range of values in ng / dl that meets the acceptable performance limits of both inaccuracy and delineation.

Device

ARCHITECT FREE T4 REAGENT

Manufacturer

ABBOTT IRELAND DIAGNOSTICS DIVISION || Imported by: ABBOTT LABORATORIES DE || COLOMBIA S.A.
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA