Events

Dimension Vista Creatinine (CRE2) 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-00801-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00801-1
  • 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 identified that dimension creatinine (cre2) assay exhibits a negative bias at the low end of the urine analytical measurement range (amr).The limit of quantitation (loq) claim (442 µmol/l) for urine samples is not met. this issue affects all future lots of cre2 until a solution is implemented. the serum/plasma cre2 amr is not affected by this issue.The bias observed for urine creatinine samples < 1149 ìmol/l would not impact clinical interpretation of adult egfr calculations or clinical interpretation of laboratory tests utilizing creatinine as a correction factor, such as urine albumin/creatinine ratio and/or urine protein/creatinine ratio.
  • 조치
    Siemens is advising users to review the maximum observed bias for low urine concentrations. It is recommended that urine CRE2 values that are less than 1149umol/L are reported as <1149umol/L rather than an actual numeric result. Siemens is providing work around instructions for users to change the lower assay range parameters to 1149umol/L. Siemens is not recommending a review of previously generated results.

Device

Dimension Vista Creatinine (CRE2) Flex reagent cartridge (Used with Dimension Vista system). An i...
  • 모델명 / 제조번호(시리얼번호)
    Dimension Vista Creatinine (CRE2) Flex reagent cartridge (Used with Dimension Vista system). An in vitro diagnostic medical device (IVD)Catalogue Number: K1033ASiemens Material Number: 10872082All lot numbers affectedARTG Number: 181689
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd