Events

Roche Clinical Chemistry tests using NAD(H) or NADP(H) reaction. 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-01025-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-10-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01025-1
  • 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
    Temozolomide may cause interference in assays using nad(h) or nadp(h). this has been confirmed in assays for gldh, ckmb and nh3, depending on the analyser used. it has been determined that the interference occurs at either very low analyte, or too high drug concentrations. these internal investigations were carried out with the therapeutic peak plasma concentration of 0.013 mg/ml temozolomide. higher drug concentrations were not systematically tested, because no literature reference for plasma concentrations > 0.013 mg/ml was found. the maximum bias for assays which showed interference at 0.013 mg/ml temozolomide is shown below:parameter % biasgldh + 62%ckmb - 31%nh3 + 36%this interference may results in falsely high or low results.
  • 조치
    Roche is advising laboratories of the potential drug interference. Test instructions for use are in the process of being updated. This action has been closed-out on 19/08/2016.

Device

Roche Clinical Chemistry tests using NAD(H) or NADP(H) reaction. An in vitro diagnostic medical d...
  • 모델명 / 제조번호(시리얼번호)
    Roche Clinical Chemistry tests using NAD(H) or NADP(H) reaction. An in vitro diagnostic medical device (IVD).Products Affected: CKMBL, Creatine Kinase-MB, GLDH3, Gen. 3, NH3 Unisys, Ammonia, NH3L, AmmoniaMaterial Numbers: 04525299190, 11929992216, 11877984216, 20766682322, 05975581190Instruments Affected: COBAS INTEGRA, cobas c 501/502, MODULAR P, cobas c 701/702ARTG Number: 174906
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited