Events

Dimension Vista Calcium (CA) 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 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-2018-RN-00106-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-02-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00106-1
  • 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 confirmed that the affected dimension vista calcium (ca) flex reagent cartridge may produce erroneously low results from specific well sets. quality control (qc) may not detect the issue prior to patient testing if the ca calibration and qc are both processed in either an affected or unaffected well set.If ca reagent calibration is performed using an unaffected well set and qc and samples are subsequently processed using an affected well set, ca results may be falsely depressed, with observed biases from -0.075 mmol/l] to -0.7 mmol/l. if a ca reagent calibration is performed using an affected well set, and qc and patient samples are subsequently processed using an unaffected well set, ca results may be falsely elevated. the observed bias for serum, plasma, and urine specimens are similar.
  • 조치
    Siemens Healthcare is advising users to discontinue use of, and discard the Dimension Vista Calcium Flex reagent lot 17171BD.

Device

Dimension Vista Calcium (CA) Flex reagent cartridge. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Dimension Vista Calcium (CA) Flex reagent cartridge. An in vitro diagnostic medical device (IVD)Catalogue Number: K1023Siemens Material Number: 10445160Lot Number: 17171BDARTG Number:181686
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd