Events

Haemoglobin A1c (HbA1c) Flex reagent cartridge used with Dimension Vista with software version 3.6.2 or higher. 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-2017-RN-01393-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01393-1
  • 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 previously confirmed that when whole blood samples are run from the small sample container (ssc), the hba1c value may contain a percent bias range of - 8.2% to + 6.5% (tga ref: rc-2014-rn-00922-1). due to this bias, use of the ssc was withdrawn. as a follow up siemens healthcare diagnostics has confirmed that the ssc can now be used with the dimension vista haemoglobin a1c (hba1c) assay with software version 3.6.2 or higher. the hba1c instructions for use beginning with lot 17205ba will detail use of the ssc.
  • 조치
    Siemens is advising users that samples for the HbA1c method can be assayed from a Small Sample Container (SSC) loaded in a “Surplus” sample rack and processed as Routine or STAT. When using an SSC, pipette a minimum of 400 uL of the whole blood sample and load in a “Surplus” sample rack using a 13mm tube insert (Do not run from a “Limited” sample rack).

Device

Haemoglobin A1c (HbA1c) Flex reagent cartridge used with Dimension Vista with software version 3....
  • 모델명 / 제조번호(시리얼번호)
    Haemoglobin A1c (HbA1c) Flex reagent cartridge used with Dimension Vista with software version 3.6.2 or higher. An in vitro diagnostic medical device (IVD)Assay: Dimension Vista HbA1CCatalogue Number: K3105ASiemens Material Number: 10470481ARTG Number: 181689
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd