Events

IMMULITE 2000 and IMMULITE 2000 XPi 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-01238-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-11-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01238-1
  • 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
    In december 2013, siemens healthcare diagnostics issued urgent recall for product correction (tga ref. rc-2014-rn-00002-1) for immulite 2000/immulite 2000 xpi androstenedione due to an observed over-recovery. during efforts to restore performance of the androstenedione assay it was confirmed that the issue noted in december 2013 was not limited to samples >5.5 ng/ml (>19.2 nmol/l). please refer to figures 1 and 2 for more information. the root cause of the over-recovery is related to the variability of a critical raw material.
  • 조치
    Siemens is requesting their customers to discard the affected lot of IMMULITE 2000/IMMULITE 2000 XPi Androstenedione. A laboratory look back is recommended for any existing androstenedione sample(s) with values generated using the affected reagent lots during the period of time within sample stability labelling, and retesting using an alternate method. This action has been closed-out on 16/05/2017.

Device

IMMULITE 2000 and IMMULITE 2000 XPi
  • 모델명 / 제조번호(시리얼번호)
    IMMULITE 2000 and IMMULITE 2000 XPi Catalogue number: SMN 10381188 Lot number: 314-323ARTG number: 179720
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division