Events

Recall of Architect / Folates-Controls;Architect / Folates-Thinner Manual

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
    2003-12-19
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-2-dmdiv-architect-folates-par-abbott-diagnostic
  • 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
    Abbott Diagnostic is withdrawing from the market. batches 94718M200 (per.31.01.04) and 04619M100 (per.28.06.04) of the in vitro diagnostic medical device called Architect / Folates-Controls - reference 6C12-1. and batches 07460M300 (per.18.06.04) and 11435M100 (per.08.09.04) of the in vitro diagnostic medical device known as Architect / Folates-Thinner Manual - reference 6C12-5. due to a lack of stability of human serum albumin in their composition; this defect may lead to lower than expected test results and lower than expected patient results for diluted samples only. Abbott Diagnostic informs affected users of the presence of the diluent in batch kits 06537M100; 09888M100; 06537M101; 05081M100; 07465M300 and 10587M200 of the in vitro diagnostic medical device called Architect / Folates Reagents - references 6C12-20; 6C12-25 and 6C12-30 and asks them, as a precaution, to no longer use the protocol "automatic dilution" with these lots .. These devices are intended for the determination of folate in serum, plasma and human erythrocytes on the Architect automaton. The results of this assay should be used in conjunction with other available data such as the results of other biological analyzes and clinical data.

Device

Architect / Folates-Controls;Architect / Folates-Thinner Manual
  • 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