Events

QUELAB Chlamydia 2SP Collection and Transport Kit 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Roche 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
    2004-06-29
  • 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-quelab-chlamydia-2sp-de-par-roche-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
    The Roche Diagnostics company withdraws from the market batches 2111 (per.08.10.04) and 2211 (per.15.10.04) of the in vitro diagnostic medical device called QUELAB Chlamydia 2SP Collection and Transport Kit - reference 207 648 09122, following the highlighting a leak at the plug of some tubes. to note :. the defect can not be detected before use of the tubes because they are stored in the frozen state and the 2SP medium contains 3 antibiotics. the results obtained for the samples from tubes which do not show any leak or are not contaminated by a defective tube are not to be questioned. This device is intended for the collection and transport of "Chlamydia" biological samples.

Device

QUELAB Chlamydia 2SP Collection and Transport Kit
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics