Events

Radiometer pCO2 membrane (D788) for ABL7/8xx analyzers 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Radiometer Medical ApS 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
    15014
  • 사례 시작날짜
    2016-11-29
  • 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: Radiometer Pacific, Unit 3, 33 Spartan Road, Takanini 2105
  • 원인
    Possible negative bias on pco2 result on both blood and qc after membrane replacement. this bias can be seen after the replacement of the membrane., update: the temporary countermeasures, regarding the additional requirement for manually narrowing the qc ranges for pco2 and also performing extra qc measurements as communicated in july 2013 are no longer required and may be revoked upon installation of the improved sealing ring on the ph electrodes in abl700 and abl800 series analyzers., 01-02-2017: this notification is to inform you that your radiometer representative has now installed the improved sealing ring for the ph electrode in your abl700 and/or abl800 series analysers.
  • 조치
    Manufacturer to issue advice regarding use

Device

Radiometer pCO2 membrane (D788) for ABL7/8xx analyzers
  • 모델명 / 제조번호(시리얼번호)
    Model: Catalogue: 942-063, Affected: all lots
  • Manufacturer
    Radiometer Medical ApS

Manufacturer

Radiometer Medical ApS