Events

Recall of AxSYM DMDIV and IMx / Folates

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
    2004-01-08
  • 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-dmdiv-axsym-et-imx-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 withdraws from the market the following batches of in vitro diagnostic medical devices called:. AxSYM / Folate. Specific thinner - reference 3C81-5. lot 05920M200 (per.21.04.04). Erythrocyte Protein Diluent - reference 3C81-6. lot 06783M100 (per.16.02.04). Medium Control - reference 3C81-1. lot 01552M100 (per.17.01.04). IMx / Folate. Medium Control - reference 2220-1. lot 06320M200 (per.10.04.04). Calibrator Mode 1 - reference 2220-4. lot 06371M200 (per.21.05.04). Specific thinner - reference 2220-5. lot 03234M300 (per.11.04.04). Controls Low and High Folate - reference 9C13-1. lots 95523M200 (per.06.03.04) and 08899M100 (per.23.08.04); due to a lack of stability of human serum albumin in their composition; this defect may lead to lower than standard test results and patient results lower than expected only for diluted samples. These devices are intended for the determination of folates in serum, plasma and human erythrocytes on the AxSYM and IMx PLCs. 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

AxSYM DMDIV and IMx / Folates
  • 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