Events

Dimension TACR (Tacrolimus) Flex Reagent Cartridge (DF107), An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Ltd Diagnostics Division 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
  • 사례 ID
    RC-2013-RN-00392-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-05-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00392-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Siemens previously communicated an issue with low bias on patient results for dimension tacrolimus flex reagent cartridge lot fa3316 (urgent medical device recall dc 13-02a and tga ref rc-2013-rn-00050-1). siemens will be implementing linking of specific dimension tacr calibrator lots with specific dimension tacr flex lots to ensure accurate recovery and continued traceability of patient results to the lcms reference method. due to the requirement for linked calibrators, lots 2ed072 and 2kd084 can no longer be used.
  • 조치
    Siemens is requesting customers to immediately discard any remaining Dimension TACR (DF107) Flex lot 2ED072 and 2KD084. To ensure the correct linkage between calibrator and reagent lots, customers are requested to contact their Siemens customer service to order lot linked combinations.

Device

Dimension TACR (Tacrolimus) Flex Reagent Cartridge (DF107), An in vitro diagnostic medical device...

Manufacturer

Siemens Ltd Diagnostics Division