Events

Dimension EXL Troponin I & Dimension Vista Digoxin, Estradiol, Ferritin, Prolactin and Thyroid Stimulating Hormone 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Siemens Healthcare Diagnostics Inc 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
    21294
  • 사례 시작날짜
    2017-10-24
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • 원인
    Update 23 october 2017 to march 2017 urgent recall for product correction regarding incorrect units for biotin listed in the non-interfering substances section of select instructions for use in dimension® and dimension vista® assays. ongoing investigation has identified the following new information regarding biotin interference:, 1. biotin interference limits are incorrectly listed in the instructions for use (ifu) for the following assays: dimension tshl, dimension ft4l and dimension vista tsh. concentrations of biotin above the concentration listed in table 2 in the revised biotin non-interference column can potentially result in interference >10%., 2. the dimension vista ctni, mmb, and dimension siro method ifus do not contain biotin interference information. concentrations of biotin above the concentration in the revised biotin non-interference column can potentially result in interference >10%.
  • 조치
    Manufacturer to issue advice regarding use

Device

Dimension EXL Troponin I & Dimension Vista Digoxin, Estradiol, Ferritin, Prolactin and Thyroid St...
  • 모델명 / 제조번호(시리얼번호)
    Model: Thyroid Stimulating Hormone (TSHL), LOCI Free Thyroxine (FT4L), Thyroid Stimulating Hormone (TSH), Cardiac Troponin I (CTNI), Mass creatine kinase MB isoenzyme (MMB), Sirolimus (SIRO), All lots (including all future lots until Instructions For Use update), Affected: DM Troponin I (TNI), DV Digoxin (DIGXN), DV Estradiol (E2), DV Ferritin (FERR), DV Prolactin (PRL), DV Thyroid Stimulating Hormone (TSH) All lots including all future lots until instructions of use is updated
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

Siemens Healthcare Diagnostics Inc