Events

Recall of Micro SSP HLA Class II Generic;Micro SSP HLA mixed classes I and II

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 ONE LAMBDA;INGEN.

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
    2004-02-18
  • 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-lots-de-dmdiv-micro-ssp-hla-de-par-ingen
  • 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 accordance with the request of the manufacturer ONE LAMBDA, INGEN withdraws from the market. batch 5A / dots 109 to 118 of the in vitro diagnostic medical device called Micro SSP HLA Class II Generic - reference SSP2L. and lot no. 5 / dots 26 to 36 of the in vitro diagnostic medical device called Micro SSP HLA mixed classes I and II - reference ABDR. following the possibility of lack of identification of DRB1 * 14 .. These devices are used for DNA typing of class I and class II HLA alleles.

Device

Micro SSP HLA Class II Generic;Micro SSP HLA mixed classes I and II
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    ONE LAMBDA;INGEN

Manufacturer

ONE LAMBDA;INGEN
  • Source
    LAANSM