Events

Chemistry 1 Calibrator used on Dimension Vista Systems (Magnesium assay calibrator). 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-00874-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-08-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00874-1
  • 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 for low recovery of magnesium (mg) quality control (qc) and patient samples following calibration of mg with the dimension vista chem 1 cal lot 3gm081. investigation by siemens confirms that qc and patient samples show low recovery of mg by 0.25 mg/dl [0.10 mmol/l] across the assay range following calibration with 3gm081.
  • 조치
    CHEM 1 CAL lot 3GM081 expired on 1 July 2014; however, Siemens is advising their customers to immediately calibrate MG with an alternate lot of CHEM 1 CAL if a calibration of MG with this lot of CHEM 1 CAL is still active. Siemens recommends that the content of this letter and review of previous testing should be discussed with your Medical Director. This action has been closed-out on 03/06/2016.

Device

Chemistry 1 Calibrator used on Dimension Vista Systems (Magnesium assay calibrator). An in vitro ...
  • 모델명 / 제조번호(시리얼번호)
    Chemistry 1 Calibrator used on Dimension Vista Systems (Magnesium assay calibrator). An in vitro diagnostic medical device (IVD).Catalogue Number: KC110Siemens Material Number: 10445169Lot Number: 3GM081ARTG number: 182222
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division