Events

Alerte De Sécurité sur ARCHITECT Anti- HBc II POSITIVE AND NEGATIVE CONTROL

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 GMBH & CO KG || Importer: ABBOTT LABORATORIES DE COLOMBIA.

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-020516
  • Numéro de l'événement
    INVIMA 2013RD-0001236-R1
  • Date
    2016-05-11
  • 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=141
  • 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
    The health agency notifies that during the labeling process of the referenced control inserts and incorrect labels were included in a limited number of kits (63). the incorrect inserts and labels belong to the architect anti-hbc ii calibrator, ln 8l44-01. however, it is considered that there is no impact on the results or the performance of the product as a result of this drawback.

Device

ARCHITECT Anti- HBc II POSITIVE AND NEGATIVE CONTROL
  • Modèle / numéro de série
    List Number (LN): 8L44-10, lot 54570LI00.
  • Description du dispositif
    IMMUNOANALYSIS CHIMIOLUMINISCENTE DE MICROPARTICULAS (CMIA) FOR THE QUALITATIVE DETECTION OF ANTIBODIES AGAINST THE ANTIGENOCORE OF HEPATITIS B VIRUS (ANTI HBC) HUMAN PLASMA AND PLASMA, INCLUDING POST-MORTEM RENEWED SAMPLES (WITHOUT CARDIAC TREATMENT).
  • Manufacturer
    ABBOTT GMBH & CO KG || Importer: ABBOTT LABORATORIES DE COLOMBIA

Manufacturer

ABBOTT GMBH & CO KG || Importer: ABBOTT LABORATORIES DE COLOMBIA
  • 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