Events

cCrea A+B Membrane Unit for use on the ABL800 series blood gas analyser range 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Radiometer Pacific Pty Ltd 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
    RC-2014-RN-01201-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-11-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01201-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Radiometer has become aware that the ccrea results for qc decreases to below the lower acceptance limit within the lifetime of the crea membranes. this has been experienced on membranes down to five days after installation of new membrane units.
  • 조치
    Radiometer is advising their customers to perform one quality control measurement using S7835 AutoCheck 6+, level 1 (Item 944-094), on already installed Crea membrane units to verify the cCrea performance. If the QC result is out of range, please install new Crea A and Crea B membranes. Until further notice the following must be carried out every 24 hours: - Perform one quality control measurement using S7835 AutoCheck 6+, level 1 (944-094) to verify the cCrea performance. - If the QC result is out of range, new Crea A and Crea B membranes must be installed. This action has been closed-out on 05/08/2016.

Device

cCrea A+B Membrane Unit for use on the ABL800 series blood gas analyser range
  • 모델명 / 제조번호(시리얼번호)
    cCrea A+B Membrane Unit for use on the ABL800 series blood gas analyser range Item Number: 942-073ARTG Number: 229300
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd