Reflotron Uric Acid (used with Reflotron Plus & Reflotron Sprint Single test chemistry systems) An in vitro diagnostic medical device (IVD) 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-2015-RN-01239-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-12-17
  • 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
    The internal investigation detected deviations in uric acid results on the reflotron system which can be above the internal specification of 5%, if the haematocrit values in whole blood samples exceed 48%. this may lead to erroneously low uric acid results in such blood samples. roche diagnostics are updating the product insert to include the revised limit.
  • 조치
    Roche Diagnostics is advising users to note the haematocrit value limit has been reduced to a maximum of 48%, and advises users to take this into account when measuring patient samples from whole blood. Roche Diagnostics will be updating the Product Insert as a permanent correction.

Device

  • 모델명 / 제조번호(시리얼번호)
    Reflotron Uric Acid (used with Reflotron Plus & Reflotron Sprint Single test chemistry systems) An in vitro diagnostic medical device (IVD)Material Number: 10745103202All lot numbers affectedARTG number: 174909
  • Manufacturer

Manufacturer