Events

Recall of TruCal APO A1 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 DiaSys GmbH.

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
    2011-03-02
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/reactif-trucal-apo-a1-diasys-gmbh-rappel
  • 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 Afssaps was informed on 16/02/2011 of the implementation of a product recall carried out by the company DiaSys GmbH .. The users concerned received the enclosed mail (02/03/2011) (1030 kb).

Device

TruCal APO A1 Reagent
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DiaSys GmbH

Manufacturer

DiaSys GmbH