Events

Dimension Vista Chemistry 3 Calibrator. 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-00236-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00236-1
  • 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 received complaints of “calibrator insert missing” alerts on the affected dimension vista chemistry 3 calibrator. internal investigation has confirmed that the vial barcode label reads kc130 instead of the correct catalogue number kc130a. when this mismatch occurs between the vial barcode label and the instructions for use (ifu) label, the “calibrator insert missing” error is triggered and displayed on the dimension vista instrument screen. there is no risk of erroneous results when this issue occurs as no results are generated.
  • 조치
    Siemens is advising users to use the re-printing options in the Vista system to re-print the affected barcodes. A review of previously generated results is at the discretion of the laboratory director.

Device

Dimension Vista Chemistry 3 Calibrator. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Dimension Vista Chemistry 3 Calibrator. An in vitro diagnostic medical device (IVD)Catalogue number: KC130ASiemens Material Number: 10711579Lot Number: 5MD004ARTG number: 182222
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd