D-dimer Test kit for AQT90 Flex (An in vitro diagnostic medical device (IVD) used as an aid in the diagnosis of venous thromboembolism) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Radiometer Pacific Pty Ltd 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-00233-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-03-13
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Radiometer has become aware that during the production process of the d-dimer test kits, a chemical reagent has been missed in a small number of test cups.
  • 조치
    Radiometer is requesting their customers to inspect their stock and remove and discard any affected lots of D-dimer test kit.

Device

  • 모델명 / 제조번호(시리얼번호)
    D-dimer Test kit for AQT90 Flex (An in vitro diagnostic medical device (IVD) used as an aid in the diagnosis of venous thromboembolism)Item Number: 942-915Batch Number: 942-91508119
  • Manufacturer

Manufacturer