Events

Various Dimension and Dimension Vista LOCI Assays. An in vitro diagnostic medical device (IVD) Thyroid Stimulating Hormone (TSHL) LOCI Free Thyroxine (FT4L) Thyroid Stimulating Hormone (TSH) Cardiac Troponin I (CTNI) Mass creatine kinase MB isoenzyme (MMB)Sirolimus (SIRO) 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-2017-RN-01350-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-10-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01350-1
  • 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
    In march 2017, siemens healthcare issued an urgent recall for product correction vc 17-04 (tga ref: rc-2017-rn-01350-1) regarding incorrect units for biotin listed in the non-interfering substances section of select instructions for use in dimension and dimension vista assays. the ongoing investigation by siemens has identified the following new information regarding biotin interference:1. biotin interference limits are incorrectly listed in the instructions for use (ifu) for the affected assays. these concentrations of biotin can potentially result in interference >10%; and2. the dimension vista ctni, mmb, and dimension siro method ifus do not contain biotin interference information. concentrations of biotin can potentially result in interference >10%.Siemens is continuing to investigate biotin interference with our assays and more information will be forthcoming. the probability of misinterpretation of results due to this issue is unlikely.
  • 조치
    Siemens is advising users of the correct biotin interference levels for the affected assays. A lookback of previously generated results is not recommended.

Device

Various Dimension and Dimension Vista LOCI Assays. An in vitro diagnostic medical device (IVD) Th...
  • 모델명 / 제조번호(시리얼번호)
    Various Dimension and Dimension Vista LOCI Assays. An in vitro diagnostic medical device (IVD)Thyroid Stimulating Hormone (TSHL)LOCI Free Thyroxine (FT4L)Thyroid Stimulating Hormone (TSH)Cardiac Troponin I (CTNI)Mass creatine kinase MB isoenzyme (MMB)Sirolimus (SIRO)Multiple Catalogue Numbers and SMNs (see attached)All Lots (including all future lots until the IFU is updated)ARTG Numbers: 182774, 182220, 180109 & 181687
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd