Events

Reflotron GPT;Reflotron GOT 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
    2004-07-16
  • 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-reflotron-gpt-et-reflotron-got-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
    Roche Diagnostics withdraws from the market:. 237 172 31 (per 30.06.05) of the in vitro diagnostic medical device called Reflotron GPT - reference 10745138. 236 651 33 (per 31.08.05); 236 652 32 (per 30.06.05). 236 653 33 (per 30.09.05) of the in vitro diagnostic medical device called Reflotron GOT - reference 10745120. following some underestimated results. These devices allow the quantitative determination, using Reflotron® devices, of GPT (pyruvic glutamic transaminase or ALAT / alanine amino transferase) or GOT (glutamic transaminase). oxaloacetic acid or ASAT / aspartate amino transferase) in blood, serum or plasma. A note. Although there have been no deficiencies reported for some of these batches, Roche Diagnostics has decided to remove them because the same component is involved in their manufacture. the results of the GPT and GOT activities should always be interpreted taking into account the history, the clinical examination and the results of other biological analyzes.

Device

Reflotron GPT;Reflotron GOT
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics