Events

Drug 4 Cal (KC460) & Drug 4 Cal (KC460A) for use with the Dimension Vista System. In vitro diagnostic medical devices (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Ltd Diagnostics Division 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-2013-RN-00171-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-02-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00171-1
  • 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 has confirmed complaints of low qc and patient recovery with the dimension vista® loci digoxin (digxn) flex® reagent cartridge when calibrating digxn with either drug 4 cal (kc460) lot 2kd052 or drug 4 cal (kc460a) lot 2kd053. internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/ml.
  • 조치
    Customers are requested to immediately discard any remaining stock. Siemens is asking customers to discuss the issues with the laboratory director so that they can determine if additional follow-up is required for patient tests conducted with the affected lots.

Device

Drug 4 Cal (KC460) & Drug 4 Cal (KC460A) for use with the Dimension Vista System. In vitro diagno...
  • 모델명 / 제조번호(시리얼번호)
    Drug 4 Cal (KC460) & Drug 4 Cal (KC460A) for use with the Dimension Vista System. In vitro diagnostic medical devices (IVD).Vista Drug 4 CalibratorCatalogue number: KC460 Siemens material number: 10472284Lot number: 2KD052 Vista Drug 4 Calibrator Lot (SMN ) Catalogue number: KC460A Siemens material number: 10476171Lot number: 2KD053 ARTG Number: 182220
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division