Recall of Prolactin AxSYM

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
    The ABBOTT DIAGNOSTIC company withdraws from the market. lots 79027Q100, 80584Q100, 83668Q100 of reference 7A62-32 Main calibrators Prolactin AxSYM. batches 78752Q100, 80548Q100 of reference 2244-22 Prolactin IMx reagent. lots 79026Q100, 80697Q100 of reference 9C07-01 Prolactin Calibrators. and batches 78753Q100, 80284Q100, 81124Q100 of reference 9C07-10 Prolactin Controls. following a decrease in the prolactin concentration that may lead to a change in the values ​​of the controls (Abbott and non-Abbott) and patients (patient results may be increased by about 20%). These reagents allow the determination of prolactin in human serum or plasma.


  • 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