Events

Roche Clinical Chemistry tests using NAD(H) or NADP(H) reaction 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 manufacturer #1479 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
    19326
  • 사례 시작날짜
    2015-11-11
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • 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 % bias, gldh + 62%, ckmb - 31%, nh3 + 36%, this interference may results in falsely high or low results.
  • 조치
    Instructions for use to be updated

Device

Roche Clinical Chemistry tests using NAD(H) or NADP(H) reaction
  • 모델명 / 제조번호(시리얼번호)
    Model: Products Affected: CKMBL, Creatine Kinase-MB, GLDH3, Gen. 3, NH3 Unisys, Ammonia, NH3L, Ammonia, Affected: All lots
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479