Recall of IMx® ß-hCG Total

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
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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 April 1, 2005, ABBOTT DIAGNOSTIC removed from market the batch 25459Q100 (expiry date 23/06/2005) of the in vitro diagnostic medical device called IMx® ß-hCG Total reference 1A06-22 following the possible occurrence of calibration errors when using this lot, related to the presence of protein aggregates in the sample diluent. This device is used for the quantitative and qualitative determination of human chorionic gonadotrophin (whole molecule and free beta subunits) in human serum and plasma for the early diagnosis of pregnancy. The company has directly notified the recipients of the batch incriminated by means of the attached message (01/04/2005) (119 ko) validated by the Afssaps. This information is intended for laboratory managers, directors of health establishments and correspondences of reaovigilance for diffusion, where appropriate, to the services concerned.


  • Model / Serial
  • Product Description
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • 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