Events

Dimension Creatinine and Dimension Vista Creatinine Assays 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-2015-RN-00680-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-07-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00680-1
  • 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 determined that dimension creatinine (crea) may produce depressed results up to 12.7% (or approximately 18 µmol/l) for a creatinine result at 133 µmol/l when haemolysis exceeds 300 mg/dl [0.19 mmol/l] of haemoglobin. dimension vista creatinine (crea) may produce depressed results up to 22% (or approximately 27 ìmol/l) for a creatinine result at 133 ìmol/l when haemolysis exceeds 200 mg/dl [0.12 mmol/l] of haemoglobin.Depressed creatinine results due to haemolysis would not be expected to significantly impact medical decisions when using this assay. the potential for injury is remote due to continued monitoring, additional diagnostic testing and correlation to patient history and presentation.
  • 조치
    A workaround is provided in the form of revised interference information via the Customer Letter.

Device

Dimension Creatinine and Dimension Vista Creatinine Assays
  • 모델명 / 제조번호(시리얼번호)
    Dimension Creatinine and Dimension Vista Creatinine AssaysDimension CREA AssayCatalogue Number: DF33A Siemens Material Number (SMN): 10444968Dimension Vista CREA AssayCatalogue Number: K1033 Siemens Material Number (SMN): 10445161All in-date and future lots are affectedARTG number: 181689
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd