Events

Safety Alert for Acetaminofen act

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by manufacturer #121.

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
    IRD-0107015
  • Event Number
    2009RD-0001527
  • Date
    2015-07-17
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=176
  • 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
    Correction report of the maximum concentration of n-acetylcysteine that can generate interference with the advia reagent acetaminophen, which applies to the advia 1200, 1800, 2400 and advia chemistry xpt chemistry systems. the initial maximum concentration of nac, whose acetaminophen results were acceptable, it was 800 mg / l. siemens again reviewed the concentration of nac and concentrations of nac 200 mg / l were obtained for a serum sample containing approximately 10 mg / dl (661 mol / l) deacetaminophen.

Device

Acetaminofen act
  • Model / Serial
    Catalog: 07989138. SMN code: 10327381 || Lots: 46251, 46564, 46369, 46370, 46619, 46782, 47001, 47157 || 47558 and future lots
  • Product Description
    Determination of the related analytes in samples from the human organism.
  • Manufacturer
    manufacturer #121

Manufacturer

manufacturer #121
  • 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