Events

Recall of Test Pack Plus hCG Combo

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 Inverness Medical France.

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
    2005-08-12
  • 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-d-un-lot-du-dmdiv-test-pack-plus-hcg-combo-inverness-medical-france
  • 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 August 10, 2005, Inverness Medical France withdrew from the market lot 17597M200 of the in vitro diagnostic medical device called Test Pack Plus hCG Combo reference 3A6016FR following the possibility of obtaining false positive results .. This device is a test immunoassay used for the early detection of pregnancy by qualitative determination of human chorionic gonadotropin (hCG) in serum and urine. In the case of a positive result, this test is confirmed by a quantitative determination in the serum. The company has directly notified the recipients of the offending lot by means of the attached message (10/08/2005) (26 KB) validated by Afssaps. The relevant European authorities concerned are informed by the manufacturer .. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Test Pack Plus hCG Combo

Manufacturer

Inverness Medical France
  • Source
    LAANSM