Dimension Vista CTNI Sample Diluent and Multi 2 Sample Diluent. An in vitro diagnostic medical device (IVD) 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-2018-RN-00277-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-03-27
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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 that some dimension vista diluent lots may have an incomplete slit on the septum in the cap of the vial. a diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the dimension vista system, due to a reduced volume of diluent being pipetted from the vial.There have been no injuries reported as a result of this issue.
  • 조치
    Siemens is advising users to inspect stock and discard any remaining stock of the affected lots. Siemens is not recommending a review of previously generated results.

Device

  • 모델명 / 제조번호(시리얼번호)
    Dimension Vista CTNI Sample Diluent and Multi 2 Sample Diluent. An in vitro diagnostic medical device (IVD) CTNI Sample DiluentCatalogue Number: KD692Siemens Material Number: 10445202Lot Number: 7BDA34Expiry Date: 01-06-2018Multi 2 Sample DiluentCatalogue Number: KD694Siemens Material Number: 10483586Lot Number: 7CDA79, 7DDA70Expiry Date: 01-09-2018, 01-11-2018ARTG Numbers: 182774 and 182222Siemens Healthcare - Troponin IVDs
  • Manufacturer

Manufacturer