Events

Recall of AlleleSEQR HLA - from QARAD

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 ATRIA.

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
    2004-11-26
  • 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-atria-alleleseqr-hla-de-la-societe-qarad
  • 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
    QARAD (manufacturer ATRIA) withdraws from the market batches of the following in vitro diagnostic medical devices:. ATRIA SEQR Allele HLA-A SBT - lot A520H04 (per 13/11/05) ATRIA SEQR Allele HLA-B SBT - lot B517H04 (per 13/11/05 ATRIA Allele SEQR HLA-C SBT - lot C520H04 (per 13 / 11/05 ATRIA SEQR Allele DRB1 SBT - lot R51J04 (per 13/11/05) ATRIA SEQR Allele DQB1 SBT-lot Q59J04 (per 13/11/05 ATRIA Allele SEQR DPB1 SBT- lot P59J04 (per 13/11 / 05), following the demonstration of a decrease in the stability time: the actual expiry dates of the DNA sequencing reaction mixtures contained in these product kits are earlier than those indicated on the product labels. The company has directly notified the recipients of the lots concerned by means of the attached message (26/11/2004) (61 KB) Letter from Atria (26/11/2004) (61 KB)

Device

AlleleSEQR HLA - from QARAD
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    ATRIA

Manufacturer

ATRIA
  • Source
    LAANSM