Events

Dimension & Dimension Vista Urine Opiates Screen assays. In vitro diagnostic medical devices (IVDs). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Healthcare Pty Ltd 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-01117-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-08-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01117-1
  • 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
    Siemens healthcare diagnostics has determined that the concentrations for some of the cross reactants listed in the specificity section of the dimension opiates assay instructions for use and the cross-reactivity section of the dimension vista opiates assay instructions for use are incorrect. siemens has revised the concentrations, which will enable the correct interpretation on how cross reactants can affect test results. the instructions for use for the opiates assay will be updated with the correct concentrations when siemens completes their investigation of the issue.
  • 조치
    Siemens is advising users to review the revised cross-reactant concentrations for Levallorphan, Levorphanol, Nalorphone and Oxycodone that are provided in the recall correspondence with their Medical Director. The decision to perform a look-back should be at the discretion of the Medical Director. Siemens will be updating the IFU with the revised concentrations once they have completed their investigation of the issue.

Device

Dimension & Dimension Vista Urine Opiates Screen assays. In vitro diagnostic medical devices (IVDs).
  • 모델명 / 제조번호(시리얼번호)
    Dimension & Dimension Vista Urine Opiates Screen assays. In vitro diagnostic medical devices (IVDs).Assay Name: Dimension OpiatesCatalogue Number: DF93ASiemens Material Number: 10444923Assay Name: Dimension Vista OpiatesCatalogue Numbers: K5093 Siemens Material Number: 10445114All lots, including all future lots until the IFU is updatedARTG Number: 182221
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd