Reflotron Hb Test Strips, an in vitro diagnostic medical device (IVD) intended for the quantitative measurement of haemoglobin in venous blood samples 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Roche Diagnostics Australia Pty Limited 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-00112-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-02-06
  • 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
    Roche diagnostics has confirmed that there is an increase in imprecision leading to higher results of the haemoglobin (hb) measurement when using capillary samples on the reflotron systems. testing with venous samples is not affected by this issue.
  • 조치
    The use of capillary blood samples with Reflotron is no longer recommended. The package insert will be amended to reflect this change. It is recommended that the recall letter is retained with the Reflotron Hb test strips until the package insert has been updated.

Device

  • 모델명 / 제조번호(시리얼번호)
    Reflotron Hb Test Strips, an in vitro diagnostic medical device (IVD) intended for the quantitative measurement of haemoglobin in venous blood samplesMaterial Number: 10744964202All lot numbers
  • Manufacturer

Manufacturer