Events

VITROS Chemistry System. An in vitro diagnostic device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ortho-Clinical Diagnostics 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-00017-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-01-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00017-1
  • 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
    Ortho clinical diagnostics, inc. (ortho) is initiating this recall action due to the need to clarify operator actions following u90-382 or 6lu condition codes generated by the vitros chemistry systems.U90-382 or 6lu condition codes are associated with wash errors that may occur when using vitros chemistry products for immuno-rate assays (i.E., vitros crbm, crp, dgxn, and phyt slides).If a u90-382 or 6lu condition code (i.E., associated with a wash error) occurs, the condition code text located on the vitros system and other user documentation indicates to dilute the sample. however, dilution may not be the appropriate action for all scenarios.For therapeutic monitoring, falsely low result due to dilution could potentially cause unnecessary drug dose increase, leading to side effects.
  • 조치
    The sponsor is advising users to follow the instructions given in the customer letter as a temporary measure when results are flagged with a Wash Error (WE) code. A software upgrade will be installed on all affected systems in the near future as a permanent fix.

Device

VITROS Chemistry System. An in vitro diagnostic device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    VITROS Chemistry System. An in vitro diagnostic device (IVD)VITROS 250 Chemistry System - Product Codes: 8132086, 6801759VITROS 350 Chemistry System - Product Code: 6802153VITROS 5,1 FS Chemistry System - Product Codes: 6801375, 6801890VITROS 4600 Chemistry System - Product Code: 6802445VITROS 5600 Integrated System - Product Code: 6802413 ARTG Number 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics