Events

HbA1c Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD) used with Dimension Vista Systems) 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-2013-RN-00315-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-04-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00315-1
  • 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
    Issue 1 - siemens healthcare diagnostics have confirmed a positive bias for values below 6%, there is a positive bias of 0.3% with an upper 95% confidence interval of 0.7%.Issue 2 - siemens healthcare diagnostics have confirmed a higher frequency of "above assay range" flags. there is a higher frequency of flags is related to higher recoveries of sample haemoglobin (hb) values (hb >25g/dl or >15.5mmol/l). the hb value is used to calculate the final output hba1c ratio (% hba1c [mmol/mol] result. results are suppressed (not reported) with the "above assay range" flag.
  • 조치
    Customers should immediately discard any remaining inventory of the affected lots of Dimension Vista® HbA1c (K3105A). Siemens will replace any unused inventory of the affected lots at no charge. Siemens is recommending customers to discuss the issues with their Medical Director to determine if additional follow up is appropriate for patient tests conducted with the lots affected.

Device

HbA1c Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD) used with Dimension Vis...
  • 모델명 / 제조번호(시리얼번호)
    HbA1c Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD) used with Dimension Vista Systems)Catalogue Number: K3105ASiemens Material Number (SMN): 10470481Lot numbers: 12072AA, 12086AA, 12107AA, 12128AA, 12150AA, 12191AA, 12212AA, 12226AA, 12248AA, 12261AA, 12282AA, 12303AAARTG: 181689
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division