Events

Automatic QC Cartridge tHb Level 1 (used with RAPIDPoint 400/405/500 instruments). 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-01237-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01237-1
  • 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 identified that certain lots of aqc have been incorrectly value assigned resulting in a +8 g/l bias for level 1 thb on rapidpoint 400/405/500 systems. some users are reporting higher than expected results for this aqc level. since the mis-assigned value is within the allowable range, there are no error flags. customers who use rilibak ranges or have tightened the aqc ranges may see a failed aqc error code.
  • 조치
    Siemens is advising users that if the Quality Control values are recovering within range, users may continue to use the current stock of AQC cartridges that they have from these lots. For users experiencing tHb running high for AQC Level 1, a suggested workaround is to reset the target tHb value for Level 1 as 188 g/L, while using the impacted cartridges. Siemens is recommending users review the letter with their Medical Director.

Device

Automatic QC Cartridge tHb Level 1 (used with RAPIDPoint 400/405/500 instruments). An in vitro di...
  • 모델명 / 제조번호(시리얼번호)
    Automatic QC Cartridge tHb Level 1 (used with RAPIDPoint 400/405/500 instruments). An in vitro diagnostic medical device (IVD)Siemens Material Number: 10310323Lot Numbers: AQC/19516, AQC/19616, AQC/20816, AQC/20916, AQC/21016, AQC/21416, AQC/21516ARTG Number: 185171
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd