ADVIA Centaur® 에 대한 현장 안전성 서한

ALIMS (Agencija za lekove i medicinska sredstva)에 따르면, 해당 현장 안전성 서한 는 Serbia 에서 SIEMENS HEALTHCARE DIAGNOSTICS INC. 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
    2014-04-25
  • 사례 출판 날짜
    2014-05-16
  • 사례 국가
  • 사례 출처
    ALIMSA
  • 사례 출처 URL
  • 비고 / 경고
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • 데이터 추가 비고
  • 원인
    Siemens healthcare diagnostics has shown that fluorescein-containing samples can show interference with advia centaur® systems tsh3 ultra, vitamin d and advia centaur brahms procalcitonin essay. research has shown that patients undergoing angiography with fluorescein can retain a small amount of fluorescein in the body from 48 to 72 hours after the procedure. in patients with renal insufficiency, retention may be significantly longer. samples containing fluorescein may give false-lower values ​​when tested with the advia _ centaur tsh3 ultra essay. on interference with florescein, the tsh3 ultra values ​​obtained may be less than 0.01 miu / l. these falsely reduced values ​​are important for monitoring patients with thyroid cancer because the physician can conclude that adequate suppression of tsh has been achieved. samples should be taken again after eliminating fluorescein to obtain tsh3 ultra results without interference. samples containing fluorescein may give false-lower values ​​when tested with the advia centaur brahms procalcitonin essay. for florescein interference, the values ​​obtained for procalcitonin may be less than <0.02 ng / ml. samples should be taken again after eliminating fluorescein in order to obtain safe results for procalcitonin without interference. samples containing fluorescein may give false elevations when tested with the advia centaur vitamin d essay. with florescein interference, the values ​​obtained for vitamin d may be > 150 ng / ml (> 375 nmol / l). samples should be taken again after eliminating fluorescein in order to obtain safe results for vitamin d without interference. the instructions for use for the advia centaur systems tsh3 ultra, vitamin d and advia centaur brahms procalcitonin tests will be supplemented to include a sentence concerning potential fluorescein interference.

Device

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  • Manufacturer

Manufacturer