Events

RAPIDPoint 400/405 Systems Measurement Cartridge (blood gas analysers). An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Healthcare 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-2016-RN-01187-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01187-1
  • 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 has confirmed an error in the value assignment for the chloride calibrators in the rapidpoint 400 and rapidpoint 405 measurement cartridge for certain cartridge serial numbers. the maximum % bias observed due to error ranges from -2.3% at 65mmol/l to +5.9% at 132 mmol/l. at extremely high chloride values (>122 mmol/l), a positive bias of 5% or greater may be observed. there have not been any reports of injury due to this issue. all the other electrolytes (na+, k+, ca++) and blood gas parameters are correctly assigned in these measurement cartridges.
  • 조치
    Siemens is advising users to review the chloride calibrators bias information provided in the recall for product correction letter with their Medical Director.

Device

RAPIDPoint 400/405 Systems Measurement Cartridge (blood gas analysers). An in vitro diagnostic me...
  • 모델명 / 제조번호(시리얼번호)
    RAPIDPoint 400/405 Systems Measurement Cartridge (blood gas analysers). An in vitro diagnostic medical device (IVD).RAPIDPoint 400 Measurement Cartridge Siemens Material Numbers (SMN): 10329756, 10341161RAPIDPoint 405 Measurement CartridgeSiemens Material Numbers (SMN): 10844812, 10283222, 10313971, 10310469Cartridge Serial Numbers: 2610900214 through 2621001325ARTG Number: 185171
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd