Events

SERUM TEST 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 EUROBIO 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 날짜
    1999-01-28
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 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
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 조치
    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900580 and "Conjugate Anti IgA ADUAL" Liquid (man, mouse) - Chamydia Panel IFI "Ref: 900169 of the company EUROBIO are withdrawn from the market These reagents have not been registered in accordance with Article L.761-14-1 of the Public Health Code at the Agence du médicament.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
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    EUROBIO

Manufacturer

EUROBIO
  • Source
    LAANSM