Events

ONLINE TDM Gentamicin assay and Preciest TDM I Calibrator. 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-2016-RN-00712-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-05-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00712-1
  • 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
    Investigations by roche have confirmed an increase in native patient sample result recovery of approximately 15 – 20% when using certain lot combinations of online tdm gentamicin with preciset tdm i calibrator. a combination with tdm control set lot 125783 does not show this effect. this may result in sub therapeutic serum levels of gentamicin leading to a delay in treatment and potentially leading to the spread of infections.
  • 조치
    Roche is advising users to immediately stop using ONLINE TDM Gentamicin reagent until further notice. Stock does not need to be discarded at this time. Users may continue to use the Preciset TDM I Calibrator for all other TDM assays on cobas c modules and MODULAR ANALYTICS (except for GENT2) and for all TDM (including GENTM) on COBAS INTEGRA systems. This action has been closed-out on 15/02/2017.

Device

ONLINE TDM Gentamicin assay and Preciest TDM I Calibrator. An in vitro diagnostic medical device ...
  • 모델명 / 제조번호(시리얼번호)
    ONLINE TDM Gentamicin assay and Preciest TDM I Calibrator. An in vitro diagnostic medical device (IVD)ONLINE TDM Gentamicin, 100 testsMaterial Number: 04490843190Lot Numbers: 119166, 611780, 617623ONLINE TDM Gentamicin, 100 testsMaterial Number: 05841291190Lot Numbers: 119167, 611783, 617624Preciset TDM I CalibratorMaterial Number: 03375790190Lot Numbers: 615118, 619681, 126387, 140735ARTG Number: 174910
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited