Events

Vancomycin Assay (performed on cobas C and Modular Analytics P-Module) 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-00783-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00783-1
  • 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
    Previously, roche had received complaints about high recovery of the vancomycin assay in the context of external survey samples. to correct this, a lc-ms/ms reference method for the quantification of vancomycin was developed and released in 2014. as a result of this, updated instrument factors were required to correct possible high recovery and to align the various roche analysers. for the cobas integra system a slight adaptation of the reagent components is required instead of an updated instrument factor. since the cobas integra reagent is not yet adapted, results generated with this reagent are still higher by up to 20% in comparison to the cobas c modules or the modular analytics p-module. the method comparison in the ifu may lead to the assumption that both methods are comparable which may affect the interpretation of vancomycin test results.
  • 조치
    Incorrect method comparison will be deleted from the IFUs. Corrected IFU will be provided to all users. In the interim, Roche is advising users to disregard the incorrect method comparison in the Instructions for Use (IFU).

Device

Vancomycin Assay (performed on cobas C and Modular Analytics P-Module)
  • 모델명 / 제조번호(시리얼번호)
    Vancomycin Assay (performed on cobas C and Modular Analytics P-Module)Online TDM Vancomycin Material Number: 04491050190Instrument affected: cobas c 501/502 moduleHitachi VancomycinMaterial Number: 04642481190 Instrument affected: MODULAR ANALYTICS P-MODULEARTG Number: 174910
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited