Events

Recall of AxSYM Homocysteine

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
    2003-08-29
  • 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-2-lots-du-dmdiv-axsym-homocysteine-ref--5f51-20-de-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
    The Abbott Diagnostic Company withdraws from the market batches 03314HN00 and 03533HN00 (per.24.01.04) of the in vitro diagnostic medical device called AxSYM Homocysteine ​​- reference 5F51-20, following the variation in performance between the different kits of the same batch . These lots should not be used anymore. A note. : if the controls are passed with each kit, their compliance with the expected specifications validates the kit; if the controls are not run with each kit, the patient results can be increased up to 90% or decreased up to 62% when the calibration is performed with one kit and the patient dosages with another from the same batch. This device allows the determination of L-homocysteine ​​in human serum or plasma on the AxSYM automaton by a fluorescence polarization technique.

Device

AxSYM Homocysteine
  • 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