Events

Cryptococcal Antigen Lateral Flow 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 IMMY 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
    2017-01-04
  • 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 affected lots’ negative predictive value remains unchanged and is nearly 100%. it is only the positive predictive value that is affected. thus, you may choose to continue to use the affected lots to report negative results and perform alternative confirmatory testing on all positive specimens. however, there are risks associated with this choice. the crag lfa is the most sensitive, commercially-available test for cryptococcal antigen. the risk associated with confirming all positive specimens with a less sensitive test is that true, low titer specimens may be negative using a less sensitive test method. thus, a true, low titer positive specimen may be incorrectly reported as negative. clinical evidence must be used in conjunction with test results. .

Device

Cryptococcal Antigen Lateral Flow Assay
  • 모델명 / 제조번호(시리얼번호)
    161028142817JH, 161019161504NZ, 161013081750KH, 161003112913JG, 161007110553JG, and 161010145035NZ
  • Manufacturer
    IMMY

Manufacturer

IMMY