Events

Recall of Free T4 Controls (9C03-10);T4 Free Reagent IMx (2222-20)

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
    2003-06-06
  • 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-controles-et-reactif-t4-libre-imx-de-la-societe-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 batches 95881Q100 and 95881Q101 (expiry date 11 February 2004) of the in vitro diagnostic medical device called Free T4 Controls (9C03-10) and lot 01550Q100 (October 28, 2003 expiry) of the device called T4 Free Reagent IMx (2222-20) due to values ​​outside the expected limits on AxSYM or IMx. Only on IMx, the simultaneous use of these batches of controls and reagent can result in a decrease in patient results up to 30% of their value with controls within the expected limits. These devices are used in the microparticulate immunoenzymological assay (MEIA) for the quantitative measurement of free thyroxine in serum or human heparinized plasma.

Device

Free T4 Controls (9C03-10);T4 Free Reagent IMx (2222-20)
  • 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