Events

RAPIDPoint 500 Measurement Cartridges used on the RAPIDPoint 500 System. An in vitro diagnostic medical device (IVD) RAPIDPoint 500 Measurement Cartridge Lactate - 750, 400, 250 and 100 tests 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-2015-RN-00855-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-09-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00855-1
  • 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
    During the manufacturing process, the sodium high calibrator value was incorrectly assigned for the rapidpoint 500 measurement cartridge causing a negative bias on both qc and patient samples.This issue causes a varying negative bias across the measurement range, with the bias increasing with increasing sodium concentrations. taking into account the magnitude of the bias near the reference interval, this issue is not expected to cause clinically significant changes to patient treatment decisions for hypernatremia.
  • 조치
    Siemens is notifying laboratories of the error and that the review of previously generated results is at the discretion of the laboratory. Laboratories are given the option to return the affected products. This action has been closed-out on 07/09/2016.

Device

RAPIDPoint 500 Measurement Cartridges used on the RAPIDPoint 500 System. An in vitro diagnostic m...
  • 모델명 / 제조번호(시리얼번호)
    RAPIDPoint 500 Measurement Cartridges used on the RAPIDPoint 500 System. An in vitro diagnostic medical device (IVD) RAPIDPoint 500 Measurement Cartridge Lactate - 750, 400, 250 and 100 testsSerial Numbers affected: 2517102517 through 2519000012.Please note: Cartridges within the affected serial number range that have a green dot on the box and/or the cartridge are not affected.ARTG Number: 176642
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd