Events

Safety Alert for Product trade name: ARCHITECT ANTI-HBc II CONTROLS / ARCHITECT ANTI-HBc II CONTROLS /// Registration number: 80146501604 /// Affected batch: 54570LI00 / / / Product hazard class: IV.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Abbott Laboratórios do Brasil; Abbott GmbH & Co. KG..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1878
  • Date
    2016-04-20
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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.
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “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