Events

ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - Troponin Ultra Ready 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-00608-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-06-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00608-1
  • 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
    Manufacturer confirms that the solid phase reagent in some of the advia centaur tni-ultra readypacks, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.
  • 조치
    Siemens is providing work around instructions to users. Only one TNI-Ultra ReadyPack is to be used on a system at one time. Patient results produced by the assay are acceptable if they follow acceptable calibration with valid quality control results. Kit lots ending in 086 or higher do not require calibration of each ReadyPack, refer IFU for the calibration interval. This action has been closed-out on 11/04/2016.

Device

ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - Troponin Ultra Ready
  • 모델명 / 제조번호(시리얼번호)
    ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - Troponin Ultra ReadyPack. An in vitro diagnostic medical device (IVD).Catalogue Numbers: 02789602 (100 tests) and 02790309 (500 tests)Lot Numbers:Kit Lots ending in 078Expiration: 18 July, 2014Kit Lots ending in 079Expiration: 18 July 2014Kit Lots ending in 082Expiration: 27 September, 2014Kit Lots ending in 083Expiration: 29 November, 2014Kit Lots ending in 084Expiration: 28 December 2014
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division