Alerta De Seguridad para Product trade name: ARCHITECT ANTI-HBc II CONTROLS / ARCHITECT ANTI-HBc II CONTROLS /// Registration number: 80146501604 /// Affected batch: 54570LI00 / / / Product hazard class: IV.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Abbott Laboratórios do Brasil; Abbott GmbH & Co. KG..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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.
  • Causa
    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. ".
  • Acción
    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.


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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