K-Tips 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Roche Diagnostics GmbH 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
    2009-11-05
  • 사례 국가
  • 사례 출처
    HPRA
  • 사례 출처 URL
  • 비고 / 경고
    Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
  • 데이터 추가 비고
    3rd Party Publications
  • 원인
    Background information or related documents: roche has confirmed a problem with k-tips (m/n: 03287343001), lots 09001108, 09002108, 09003108, 09004108, 09005108, 09006108, 09007108, 09008108 and 09009108, which are for use with the cobas® ampliprep instrument. the affected lots contain k-tips that are completely closed (near the pipetting end of the k-tip), which prevents the cobas® ampliprep instrument from pipetting eluate from the spu into the k-tube. roche has confirmed that use of these defective k-tips will result in an invalid run and no reportable results. roche is recalling all affected lots. further information is available in the field safety notice below. important safety information - k tips note: field safety notices are placed on our website for information purposes. you will not normally need to take further action unless the manufacturer has contacted you directly or we have issued additional advice.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    K-Tips - Important Safety Information from Roche Diagnostics GmbH
  • Manufacturer

Manufacturer