Events

Roche ProCell/CleanCell Aspiration Tube Filters 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 manufacturer #1479 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    16654
  • 사례 시작날짜
    2014-05-08
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • 원인
    The manufacturer has identified that under certain conditions the white aspiration tube/filters on the end of the procell and cleancell aspiration tubes may become loose or fall off the aspiration tube completely. this in turn may allow air to enter the aspiration tube, creating foam. the liquid short sensors (lss) are unable to detect these very small bubbles. foam may be visible in the procell and cleancell reservoirs. if foam reaches the measuring cells, this may cause discrepant results. the magnitude of the discrepancy will vary with the amount of air being aspirated, particularly for procell.
  • 조치
    Instructions for use to be updated

Device

Roche ProCell/CleanCell Aspiration Tube Filters
  • 모델명 / 제조번호(시리얼번호)
    Model: Part number: 03149773001, Affected: All lots
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479