Events

Recall of TestPack + Plus HCG Combo with OBC reagent

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 Unipath Ltd.

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
    2008-12-31
  • 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-deux-lots-de-reactif-testpack-plus-hcg-combo-with-obc-de-la-societe-unipath-ltd
  • 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
    In agreement with Afssaps, Unipath Ltd, on 29.12.08, recalled two batches of TestPack + Plus HCG Combo with OBC reagent due to a lack of performance. The users of this device concerned by this defect in France have received the enclosed letter (31/12/2008) (78 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for distribution to the concerned biology departments.

Device

TestPack + Plus HCG Combo with OBC reagent
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Unipath Ltd

Manufacturer

Unipath Ltd
  • 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