Events

Radiometer ABL90 Series Blood Gas Analysers 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
    21043
  • 사례 시작날짜
    2017-01-24
  • 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
    On the abl90 series analyzers the sample type cord blood has been changed into the two sample types cord blood arterial and cord blood venous. this change took place with software version 3.1 mr5. the selected sample type is displayed correctly on the abl90 series analyzer itself. irrespective of the sample type selected on the abl90 series analyzer during sample processing, the analyzer will transmit the less specific sample type cord blood to a his/lis or middleware system., an operator who is aware that the sample types that can be selected on the abl90 series analyzer are cord blood arterial and cord blood venous may notice that a less specific sample type cord blood appears in the his/lis or middleware system., error may in a worst-case scenario lead to minor fetal hypoxic stress not being immediately recognized if the clinician was to use data from the his/lis or middleware system to determine treatment., this may cause a delay of treatment for newvborn infant.
  • 조치
    Software to be upgraded

Device

Radiometer ABL90 Series Blood Gas Analysers

Manufacturer

Radiometer Medical ApS