Events

Dimension Vista Systems Mass CKMB Isoenzyme Calibrator (MMB CAL). An in vitro diagnostic medical device (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-2014-RN-01084-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-10-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01084-1
  • 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 vista mass ckmb isoenzyme calibrator (mmb cal) shows drift during routine stability monitoring that exceeds siemens acceptance criteria for drift over the shelf life of this product. siemens has observed drift from 3% to 12% at mmb concentrations across the assay range. depending on quality control limits, this drift may not have been detected. due to the drift, siemens is revising the expiration date of this product. the manufacturer has confirmed routine stability monitoring data for mmb cal only supports six months. product is labelled for 12 months.
  • 조치
    Siemens Healthcare Diagnostics is requesting the customers to discard any remaining inventory of MMB CAL lots and to recalibrate with lot 4FD073 on next calibration. Review of previous testing is at discretion of the laboratory. This action has been closed-out on 04/04/2017.

Device

Dimension Vista Systems Mass CKMB Isoenzyme Calibrator (MMB CAL). An in vitro diagnostic medical ...
  • 모델명 / 제조번호(시리얼번호)
    Dimension Vista Systems Mass CKMB Isoenzyme Calibrator (MMB CAL). An in vitro diagnostic medical device (IVD)Siemens Material Number: 10445195Test Code: 0317Catalogue Number: KC672Lot Numbers: 3JD045,4BD064, 4CD012, 4DD065ARTG Number 182776
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division