Events

Simplexa™ Flu A/B & RSV Direct assay Simplexa™ HSV 1 & 2 Direct assay 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 Focus Diagnostics 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
    2014-05-15
  • 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
    The purpose of this letter is to advise you that focus diagnostics is providing an urgent safety notice for a correction to the labeling for simplexa™ flu a/b & rsv direct (mol2650) and simplexa™ hsv 1&2 direct assays (mol2150). focus diagnostics received some customer complaints of simplexa flu a/b & rsv direct assays with sporadic false signals, which may result in a higher false results rate due to a potential software spectral matrix and direct amplification disc storage. to date, focus has not received any complaints for the simplexa hsv 1 & 2 direct assay used for commercial use. focus diagnostics is not requesting removal of any products from the test facility, but you should take extra precautions as described in the updated labeling. .

Device

Simplexa™ Flu A/B & RSV Direct assay Simplexa™ HSV 1 & 2 Direct assay

Manufacturer

Focus Diagnostics