Events

Glucose, and others 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 Thermo Fisher Scientific 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
    2015-09-22
  • 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
    N-acetylcysteine (nac), acetaminophen via its metabolite n-acetyl-p-benzoquinone imine (napqi), and metamizole may cause interferences in so-called trinder reactions. trinder reactions are based on a colorimetric reaction between hydrogen peroxide (h2o2), aminoantipyrine and a phenol derivate catalyzed in the presence of a peroxidase. peroxidase reactions might be interfered by above mentioned medications, which may lead to falsely low recovery. it has been recently noticed that the above mentioned possible interference applies widely to products with trinder methodology, regardless of the manufacturer. .

Device

Glucose, and others
  • 모델명 / 제조번호(시리얼번호)
    Glucose (GOD-POD) 981379, 981780 Uric Acid (AOX) 981391, 981788 All Lots Triglycerides 981301, 981786 Cholesterol 981812, 981813 Creatinine (Enzymatic) 981845, 981896 HDL- Cholesterol Plus 981824,981823 LDL-Cholesterol 981656
  • Manufacturer
    Thermo Fisher Scientific Inc.

Manufacturer

Thermo Fisher Scientific Inc.