Events

IMMULITE 2000/IMMULITE 2000 XPi water and liquid waste bottles 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-2015-RN-00201-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-03-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00201-1
  • 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 is conducting a correction for the immulite 2000 / immulite 2000 xpi immunoassay systems water and liquid waste bottles received from may 2013. siemens has identified that the water and liquid waste bottle assemblies were manufactured with a quality issue. the opening of both bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.This could result in the aspiration straw dislodging from the bottle causing the instrument to aspirate air into the fluidic line potentially resulting in discordant results.
  • 조치
    Siemens is providing work around instructions to assist end users to mitigate risk and identify faulty bottle openings. If a faulty bottle is identified end users are requested to contact Siemens for a replacement.

Device

IMMULITE 2000/IMMULITE 2000 XPi water and liquid waste bottles
  • 모델명 / 제조번호(시리얼번호)
    IMMULITE 2000/IMMULITE 2000 XPi water and liquid waste bottlesSiemens Material Numbers: 10291586 and 10291587ARTG number: 174399
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division