Events

Alerte De Sécurité sur Product trade name: ARCHITECT ANTI-HBc II CONTROLS / ARCHITECT ANTI-HBc II CONTROLS /// Registration number: 80146501604 /// Affected batch: 54570LI00 / / / Product hazard class: IV.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Abbott Laboratórios do Brasil; Abbott GmbH & Co. KG..

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
    1878
  • Date
    2016-04-20
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    Risk assessment was not required as there is no impact on patient outcomes or product performance as a consequence of this problem. / / There is no impact on patient outcomes or product performance as a consequence of this problem./// We ask apologies for any inconvenience caused. Abbott is committed to providing the highest quality diagnostic products and support services to meet the needs of its laboratory, suppliers and patients.
  • Cause
    The company clarifies that "during the labeling process of the architect anti-hbc ii control, list number (ln) 8l44-10, lot 54570li00, an incorrect use statement (ifu) and country-specific label were inserted / applied to a limited number of kits (63). the incorrect ifu / country-specific label was from the architect anti-hbc ii calibrator, ln 8l44-01. ".
  • Action
    Risk classification: IV /// Field action classification: product recall for further destruction /// Field action code: FA14APR2016 /// Recommendations to users and patients: discontinue use of the ARCHITECT Anti-HBc Control kits II of lot 54570LI00; if you are currently using or have the aforementioned batch in stock, immediately contact Customer Support; the remaining stock of the batch will be collected and destroyed by an Abbott representative /// If you have shipped the product specified above to other laboratories, please inform them about this Product Recall and provide them with a copy of this release. Keep this notice in your lab records.

Device

Product trade name: ARCHITECT ANTI-HBc II CONTROLS / ARCHITECT ANTI-HBc II CONTROLS /// Registrat...

Manufacturer

Abbott Laboratórios do Brasil; Abbott GmbH & Co. KG.
  • 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
    ANVSANVISA