Events

Recall of SERUM TEST

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 EUROBIO.

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
    1999-01-28
  • 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-tous-les-lots-des-reactifs-denommes-serum-test-de-la-societe-eurobio-retrait-de-tous-les-lots
  • 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
    All batches of reagents referred to as. "Triclonal total human albuminous anti-D (RH1) serum test (Euclone IgG + IgM)" Ref: 910006, 910022. "Euclone human polyclonal Anti-D (RH1) test serum" - Ref: 910031, 919314 and included in Ref : 910032, 919347. "Euclone polyclonal Anti-E (RH3) test serum" Ref: 910036, 919333. "Euclone human polyclonal anti-e (RH5) test serum" Ref: 910038, 915418. "Test serum Anti-E Euclone human polyclonal c (RH4) "Ref: 910037, 915411." Anti-Kell (K1) plate and human polyclonal Coombs Euclone test serum "Ref: 910040, 915442." Negative control for albuminous Euclone polyclonal "Ref: 910042, 919319 and included in Ref: 910032, 919347. "IgA kit - Chlamydia Panel IFI" Ref: 900580 and "Conjugate Anti IgA ADUAL" Liquid (man, mouse) - Chamydia Panel IFI "Ref: 900169 of the company EUROBIO are withdrawn from the market These reagents have not been registered in accordance with Article L.761-14-1 of the Public Health Code at the Agence du médicament. A reagent can not be used to evaluate the reagent's performance and reliability criteria, which can lead to risks to public health.

Device

SERUM TEST
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    EUROBIO

Manufacturer

EUROBIO
  • Source
    LAANSM