Events

Safety Alert for ARCHITECT SYSTEM / ARCHITECT SYSTEM. Anvisa Record: 10055311134. Affected Model: c8000 (with the following software versions: 2.20, 2.20DB, 2.60, 3.10, 3.11 and 3.12).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Abbot Laboratories; Abbott Laboratórios do Brasil Ltda – Divisão Diagnósticos..

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
    947
  • Date
    2008-11-03
  • 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 Abbott Ltd, good laboratory practice with respect to sample handling can minimize the occurrence of the suction error in the pressure monitoring (Error Code: 3375), thereby reducing the incorrect suction potential of the subsequent sample. Some causes of Error Code 3375 are as follows: (1) Presence of fibrin when a sample is centrifuged prior to complete clot formation; (2) Presence of bubbles, foam or clot in the sample; (3) Inadequate sample volume in sample or tube cuvette; (4) Presence of particulate matter, fibrin or blood cells in stored samples. The Technovigilance Unit is following up on this case.
  • Reason
    The architect c8000 system software can allow the required tests for one sample to be aspirated from a different sample under different conditions. the defect can occur when an aspiration error (error: 3375 - unable to process test, aspiration error occurred) is generated during the test.
  • Action
    Abbott Laboratories of Brazil Ltda has already initiated a corrective action, aiming to update the versions of software under risk by an updated version (version 3.13). According to company information, corrective action has already been reported to customers through FA-11. Until the software update is performed, the following actions are required for users of the product: Configure your ARCHITECT system to ensure that the results are not released by the laboratory until: (1) it is verified that no samples have been flagged with Error Code 3375; or (2) until the retests for those samples that have submitted Error Code 3375 are completed. This can be achieved in two distinct ways: (1) Retention of the result transmission in the ARCHITECT System Control Center - SCC); (2) Retention of the transmission of results in the middleware (Distributed Computing System) or LIS. For more details, see the Required Actions item described in the Letter to Customers (http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/947_carta.pdf). To access the Verification Form, see http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/947_formulario.pdf

Device

ARCHITECT SYSTEM / ARCHITECT SYSTEM. Anvisa Record: 10055311134. Affected Model: c8000 (with the ...

Manufacturer

Abbot Laboratories; Abbott Laboratórios do Brasil Ltda – Divisão Diagnósticos.
  • 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