Events

Combur10 Test UX when measured on Urisys 1100. 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-2018-RN-00349-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-05-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00349-1
  • 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
    Roche has changed the performance claims for the combur10 test ux when measured on the urisys 1100 analyser.Roche performed internal performance studies, in order to maintain products’ compliance to current regulatory requirements. these studies determined that the limit of detection (lod) of certain parameters when measured on the urisys 1100 analyser varied from the claims stated in the ifu current at the time of testing.Parameters with changed lod are: protein, nitrite, ketone bodies, leukocytes, and blood: intact erythrocytes. note:values for all other parameters measured by the combur10 test ux remain unchanged.The lower lod for visual reading remains unchanged for all parameters.Roche has received no customer complaints worldwide in relation to this issue.
  • 조치
    Roche is advising users to verify negative results for Protein, Nitrite, Ketone bodies, Leukocytes or Blood (intact erythrocytes), by visual reading, using the colour scale provided on the test strip vial. In case of discrepant values, the visually determined value shall be reported.

Device

Combur10 Test UX when measured on Urisys 1100. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Combur10 Test UX when measured on Urisys 1100. An in vitro diagnostic medical device (IVD)Material Number: 11544373049 (100 tests)All Lots lower than 29896103ARTG Numbers: 224003 (Roche Diagnostics Australia - Clinical chemistry biological screening IVDs) 212706 (Roche Diagnostics Australia - Instrument/analyser IVDs)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited