Events

Safety Alert for Architect diagnostic kit ANTI-HBc II reagents; Brand: Abbott, Registration: 80146501602, Serial numbers: 42072LI00, 42072LI01, 42253LI00 and 42253LI01.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ABBOTT LABORATÓRIOS DO BRASIL LTDA; 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
    1536
  • Date
    2015-02-25
  • 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
    According to company information there is potential for occurrence of false-positive results. There is no impact on the sensitivity of the assay and the risk is associated with misunderstanding that a patient is infected with the HBV virus and performing additional tests.
  • Reason
    Reduction of specificity to 99.2% and increase of the false-positive result in the tests carried out in the architect anti-hbc ii kit. the specificity value is below the specifications found in the instructions for use which is 99.5%.
  • Action
    The company asks customers to discontinue use of the affected lots, complete the customer response form, and disclose information about the problem in the diagnostic kits and any additional tests that may be performed.

Device

Architect diagnostic kit ANTI-HBc II reagents; Brand: Abbott, Registration: 80146501602, Serial n...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA; 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