Events

Recall of ARCHITECT ® anti-HBs reagents

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by ABBOTT DIAGNOSTIC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2004-09-14
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retraits-de-lots-du-dmdiv-architect-reactifs-anti-hbs-de-par-abbott-diagnostics
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
  • Extra notes in the data
  • Action
    On September 13, 2004, Abbott Diagnostics withdrew from the market. lots 17048M100 (per.07.04.05); 10014M200 (per.05.01.05); 09140M300 (per.17.10.04) and 08672M200 (per.16.10.04) of the reference 7C18-20. the lot 10014M201 (per.05.01.05) of the reference 7C18-2. and batches 13251M100 (per.01.06.05) and 10015M200 (per.06.01.05) of reference 7C18-3. of the in vitro diagnostic medical device called ARCHITECT ® anti-HBs reagents, following the detection of a stability problem that could lead to calibration failures, to non-standard quality control values ​​and sometimes to non-standard results. Discordant patients. This device allows the assay of anti-HBs antibodies (antibodies against hepatitis B virus surface antigen) in human serum or plasma, on the ARCHITECT automaton.

Device

ARCHITECT ® anti-HBs reagents
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    ABBOTT DIAGNOSTIC

Manufacturer

ABBOTT DIAGNOSTIC
  • 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
    LAANSM