Events

Alerte De Sécurité sur Acetaminofen act

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par manufacturer #121.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    IRD-0107015
  • Numéro de l'événement
    2009RD-0001527
  • Date
    2015-07-17
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=176
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    Catalog: 07989138. SMN code: 10327381 || Lots: 46251, 46564, 46369, 46370, 46619, 46782, 47001, 47157 || 47558 and future lots
  • Description du dispositif
    Determination of the related analytes in samples from the human organism.
  • Manufacturer
    manufacturer #121

Manufacturer

manufacturer #121
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “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