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Dimension®, Dimension Vista® 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Siemens Healthcare d.o.o. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 날짜
    2017-04-12
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    Siemens healthcare diagnostics has confirmed that dimension tni and dimension vista digxn, e2, ferr, prl, tsh operating instructions (ifu) under the non-interfering substances section of the biotin concentration unit are incorrect, indicating a concentration level at which biotin does not constitute interference. in the case of tni, e2, ferr, prl and tsh, biotin represents a significant interference at the indicated concentration. in the case of the dimension vista e2, which is a competitive test, biotin interference shows a positive deviation, while in the other tests (sandwich methods) it shows a negative deviation.

Device

Dimension®, Dimension Vista®
  • 모델명 / 제조번호(시리얼번호)
    Dimension Troponin I (TNI) RF621 10464525 All lot numbers up to update Operating Instructions (IFU) Dimension Vista Digoxin (DIGXN) K6435 10488927 All lot numbers up to update Operating Instructions (IFU) Dimension Vista Estradiol (E2) K6463 10489099 All lot numbers up to update Operating Instructions (IFU) Dimension Vista Ferritin (FERR) K6440 10445136 All lot numbers up to update Operating Instructions (IFU) Dimension Vista Prolactin (PRL) K6462 10488398
  • Manufacturer
    Siemens Healthcare d.o.o.

Manufacturer

Siemens Healthcare d.o.o.