Events

Dimension Vista Systems - Theophylline (THEO) Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Ltd Diagnostics Division 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-2014-RN-01206-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2014-11-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01206-1
  • 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 confirmed abnormal reaction flags (e145: abnormal reaction) with dimension vista theophylline (theo) flex reagent cartridge lot 14148ac. the abnormal reaction flags can occur on calibration, qc and/or patient samples. any result with an abnormal reaction flag is deemed non-reportable as described in the dimension vista operator’s guide.The potential for an abnormal reaction flagged result when using the affected lots would prevent reporting theophylline values. the frequency of obtaining abnormal reaction flags as a result of this issue is variable among customer sites ranging from 0 flags to 100% of results flagged.
  • 조치
    Siemens is requesting their customers to discontinue use and discard any remaining inventory of Dimension Vista THEO lot 14148AC. Siemens will replace any unused inventory of the affected lot at no charge. This action has been closed-out on 02/03/2016.

Device

Dimension Vista Systems - Theophylline (THEO) Flex Reagent Cartridge. An in vitro diagnostic medi...
  • 모델명 / 제조번호(시리얼번호)
    Dimension Vista Systems - Theophylline (THEO) Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD).Catalogue Number: K4071Lot Number: 14148ACARTG Number: 182220
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division