Blood Urea Nitrogen (BUN) Flex Reagent Cartridge (used with Dimension Vista System). 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-00211-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-02-26
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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 determined that affected lots of dimension vista blood urea nitrogen (bun) may exhibit inaccurate patient and/or qc results. the issue has been isolated to flex reagent cartridges manufactured from specific mold cavities. investigations indicate a loss of activity of the gldh reagent wells from specific mold/cavity identifiers. not all flexes are affected.·if calibration is performed using an unaffected well and patient results are subsequently run using an affected well, bun results may be falsely depressed by up to approximately 50% across the concentration range tested of 3.9 – 280 mmol/l (11–784 mg/dl). · if calibration is performed using an affected well, bun results may be falsely elevated by up to approximately 64% across the concentration range tested of 5.4 – 264 mmol/l (15–740 mg/dl)the risk to health as a result of this issue is remote and limited to falsely depressed bun results which may potentially result in the delay in the follow-up for kidney disease.
  • 조치
    Siemens is advising users to inspect the affect products to determine if the cartridges have the affected Cavity Number, and discard any cartridges that have the specific lot and cavity number combinations. Cartridges which do not have the affected cavity numbers are unaffected and can continue to be used. Siemens is not recommending a review of previously generated results, however please discuss this letter with your Medical Director and consider the need for a look back at patient results generated with the affected cartridges.

Device

  • 모델명 / 제조번호(시리얼번호)
    Blood Urea Nitrogen (BUN) Flex Reagent Cartridge (used with Dimension Vista System). An in vitro diagnostic medical device (IVD)Catalogue Number: K1021Siemens Material Number: 10445159Lot Numbers: 15215AE, 15243BB, 15264BA, 15299BB, 15300BA, 15320BB and 15341ACAffected Flex Cavity Number: B1, C3, C3, B3, B3, B1 and B4ARTG Number: 181689
  • Manufacturer

Manufacturer