Events

Dimension Vista Hemoglobin A1c Flex Reagent Cartridge. 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-01030-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-09-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01030-1
  • 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 has confirmed that the dimension hb1c flex reagent cartridge lots listed1 exhibit a positive bias averaging 0.4% [4.4 mmol/mol] haemoglobin a1c units and occasionally up to 1.0% [11 mmol/mol] hba1c units for patient samples when compared to the national glycohemoglobin standardization program (ngsp).
  • 조치
    Siemens is advising their customers to discontinue use and discard the affected lots. Retesting HbA1c should be considered in cases where all of the following events have occurred: - HbA1c testing was performed on your patient(s) using the affected lot numbers - There may have been adjustments in therapy based solely on the HbA1c value(s), - There have been no follow up HbA1c testing on the patient since the discontinuation of use of the affected lot numbers. This action has been closed-out on 10/08/2016.

Device

Dimension Vista Hemoglobin A1c Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Dimension Vista Hemoglobin A1c Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD)Catalogue Number: DF105ASiemens Material Number: 10483822Lot Numbers: GA4266, BA4273, BA4280, BA4287, GA4301, GA4315, GC4322, GA4343, GA4350, GA4357, GA5013 & GA5020ARTG Number: 181689
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division