Events

Recall of ID-DiaCell I-II-III

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 Diamed.

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
    2005-11-03
  • 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-du-dmdiv-id-diacell-i-ii-iii-diamed
  • 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
    On October 31, 2005, the company DIAMED removed from the market the lot 45184.47.1 (per 14/11/2005) of the reference 004310 and the lot 45404.47.1 (per 14/11/2005) of the reference 004304 of the in vitro diagnostic medical device referred to as ID-DiaCell I-II-III. These are test red cells for ID-Micro Typing System, for Irregular Antibody Research (RAI). This measure follows an isolated problem encountered with an anti-E antibody, probably natural, of low titer, not detected in cardiac indirect Coombs technique with gelatin n 2, phenotype R2R2 (D + C-E + c + e-) of these two screening panels. To date, there is no evidence to suggest that the red cell 2 has a major problem of expression of the E antigen (control and confirmation of the Rhesus / Kell phenotype, human anti-E antibody patients). Investigations are in progress at the National Reference Center for Blood Groups (CNRGS). The company has directly notified the recipients of the incriminated lots by means of the attached message (31/10/2005) (12 KB) validated by the Afssaps .. This information is intended for laboratory managers, directors of health establishments and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

ID-DiaCell I-II-III
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Diamed

Manufacturer

Diamed
  • Source
    LAANSM