Events

True- Sign hCG reference V9900 (200 tests) 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 ServiBio 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
    2005-09-12
  • 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-du-dmdiv-true-sign-hcg-servibio
  • 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 09 September 2005, the company ServiBio withdrew from the market batches 2005032301 (per 09/2006), 200506903 (per 12/2006) and 2005071001 (per 01/2007) of the in vitro diagnostic medical device called True- Sign hCG reference V9900 (200 tests) following the detection of false negative results. This device is a qualitative first-line test for the detection of hCG in serum and urine, for the biological diagnosis of pregnancy. The company has directly notified the recipients of the incriminated lots by means of the attached message ( 09/09/2005) (15 KB) validated by the Afssaps. This message is completed by a letter Afssaps (09/09/2005) (25 ko) on the modalities to follow for the patients whose hCG screening would have been found negative with the aforementioned lots. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

True- Sign hCG reference V9900 (200 tests)
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    ServiBio

Manufacturer

ServiBio
  • Source
    LAANSM