Events

Alerte De Sécurité sur Chemiluminescent immunoanalysis - Anti-HB II

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 ABBOTT LABORATORIOS.

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
    RRD-010315
  • Numéro de l'événement
    2013RD-0001236R1
  • Date
    2015-03-04
  • 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=184
  • 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
    Failure in reporting results in urls (relative units of light) which causes a decrease in specificity and a rise in false reactive results.

Device

Chemiluminescent immunoanalysis - Anti-HB II
  • Modèle / numéro de série
    Reference. 8L4425 Lots: 42072LI00, 42072LI01, 42253LI00, 42253LI01, Reference.8L44-30 Lots 42255LI00, 4225LI01, Reference. 8L44-35 Lot 42256LI00
  • Description du dispositif
    Chemiluminescent immunoanalysis of macroparticles for the qualitative detection of antibodies against the CORE antigen of Hepatitis B virus (ANTI HBC) in serum and human plasma including samples collected POSTMORTEM
  • Manufacturer
    ABBOTT LABORATORIOS

Manufacturer

ABBOTT LABORATORIOS
  • 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