Events

Recall of DAKO TPHA SYPHILIS

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 J2L ELITECH.

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
    2002-11-04
  • 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-dako-tpha-syphilis-de-j2l-elitech
  • 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, J2L ELITECH withdraws from the market lot 221801 (per.31.01.04) of the in vitro diagnostic medical device called: DAKO TPHA SYPHILIS - ref. KD514 (Dako) / 0404-VKD51411 (J2L), due to non-compliance of the instructions included in the enclosures.

Device

DAKO TPHA SYPHILIS
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    J2L ELITECH

Manufacturer

J2L ELITECH
  • Source
    LAANSM