Events

RAPIDPoint 500 Measurement Cartridges. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Ltd Diagnostics Division 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-00601-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2014-06-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00601-1
  • 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
    Siemens healthcare diagnostics has received several reports from customers of one or more electrolyte parameters (e.G., na+, ca++, k+, cl-) reporting a “-----?” error code when aqc, qc, or cvm is run on the rapidpoint 500 blood gas analyzer. when exhibited, the issue is usually seen during level 1 qc /aqc, level 1 cvm, and sometimes level 2 cvm testing. this issue has also been observed on a small number of patient samples.
  • 조치
    Customers are advised that the following steps can be taken to mitigate the issue: - Install a RAPIDPoint 500 Measurement Cartridge or - Install a 405 Measurement Cartridge. Customers will need to arrange to get the lactate results from other instruments in their central laboratory since the Lactate parameter is not available on the RAPIDPoint 405 cartridge or - Use an alternative system to obtain the electrolyte values. Since this issue is not related to the AQC cartridge, installing a new AQC cartridge will not solve the problem.

Device

RAPIDPoint 500 Measurement Cartridges. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    RAPIDPoint 500 Measurement Cartridges. An in vitro diagnostic medical device (IVD)Part numbers: 10844813, 10491447, 10491448 & 10491449Serial Numbers: 2334500011 to 2412705915ARTG number: 176642
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division