Events

Calibrator 30 (2 pack) used with ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, Centaur XP and Centaur XPT systems. 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-2017-RN-00747-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-06-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00747-1
  • 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 confirmed a negative bias for advia centaur enhanced estradiol (ee2) on the advia centaur, advia centaur xp and advia centaur xpt systems when calibrating with calibrator 30 kit lots ending in 21 (c3021) as compared to calibrator 30 kit lots ending in 20 (c3020). siemens’ internal investigation has determined that samples with estradiol concentrations of approximately 35 pg/ml (128 pmol/l) and lower exhibit a % bias greater than the expected historical performance of the product when comparing c3021 to c3020. results observed indicate that as estradiol concentrations increase, the % biases observed become less pronounced.
  • 조치
    Siemens is advising users to discontinue use of and discard the Calibrator 30 kit lots 00387A21, 16673A21 and 36243A21. Replacement product will be provided. Calibrator 30 kit lots ending in 20 and 23 are not impacted and can be used.

Device

Calibrator 30 (2 pack) used with ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, Cen...
  • 모델명 / 제조번호(시리얼번호)
    Calibrator 30 (2 pack) used with ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, Centaur XP and Centaur XPT systems. An in vitro diagnostic medical device (IVD).Calibrator 30 Siemens Material Number (SMN): 10379810Lot Numbers: 00387A21, 16673A21, 36243A21Expiry: 8 March 2018ARTG Number: 175698
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd