Events

ADVIA Centaur CA 19-9 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 BAYER DIAGNOSTICS 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
    2004-08-30
  • 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-lots-des-dmdiv-ca-19-9-advia-centaur-et-acs-180-de-par-bayer-diagnostics
  • 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
    On 27.08.04, Bayer Diagnostics withdrew from the market batches 75 (per 13.12.04) and 78 (per 22.02.05) of the in vitro diagnostic medical device known as ADVIA Centaur CA 19-9 - references 03481938 ( 250 tests) and 04612750 (50 tests) and lot 76 (per 24.12.04) of the in vitro diagnostic medical device called ACS: 180 - references 04412689 (300 tests) and 01569439 (50 tests), following the implementation of evidence of sensitivity to heterophile antibodies potentially present in patient samples larger than that of previous batches; this may lead to higher results than expected. These devices are used for the determination of the CA 19-9 tumor marker on the ADVIA Centaur and ACS: 180 analyzers.

Device

ADVIA Centaur CA 19-9
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    BAYER DIAGNOSTICS

Manufacturer

BAYER DIAGNOSTICS
  • 제조사 모회사 (2017)
    Bayer AG
  • Source
    LAANSM