Events

cobas p 512 pre-analytical system (64x) and cobas p 612 pre-analytical system (63x) 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 Roche 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
  • 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
    Roche diagnostics received complaints from two customers that un-spun samples were incorrectly identified as “spun” by the spin status detection on cobas p 512 (64x) pre-analytical system. when non-centrifuged samples incorrectly identified as “spun” are further analyzed, erroneous results may occur and relevant medical risk cannot be entirely excluded. this case made us aware that we need to provide a better specification on the intended use of the spin status detection. the cobas p 512 (64x) and the cobas p 612 (63x) systems are not designed to make a sorting decision based on the spin status detection functionality. while investigating these complaints, we identified that all documentation related to .

Device

cobas p 512 pre-analytical system (64x) and cobas p 612 pre-analytical system (63x)
  • 모델명 / 제조번호(시리얼번호)
    All cobas p 512 (64x) pre-analytical system All cobas p 612 (63x) pre-analytical system
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics