Events

RAPIDQC Complete Quality Control Material (QC reagent for use with blood gas instruments). 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-00702-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00702-1
  • 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
    There is an error in the expected values chart pertaining to the level 2 ph control range for all siemens blood gas instruments. due to this error, the recovery of ph for rapidqc complete, level 2, lot number 362303, is elevated. it is also possible that some instruments may, on occasion, recover ph out of range high. however, the published target ranges for all other analytes are unaffected.
  • 조치
    Siemens is providing their customers with the correct pH range assignments (in pH and H+ units) and corresponding barcodes for all the Siemens blood gas systems. End users are requested to re-enter the corrected pH target ranges, or rescan these barcodes into the blood gas system to replace the ones in the Expected Values Chart and keep this notice with the control material. Repeat testing of any patient samples is at the discretion of laboratory.

Device

RAPIDQC Complete Quality Control Material (QC reagent for use with blood gas instruments). An in ...
  • 모델명 / 제조번호(시리얼번호)
    RAPIDQC Complete Quality Control Material (QC reagent for use with blood gas instruments). An in vitro diagnostic medical device (IVD).Lot Number 362303ARTG Number: 185171
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division