Events

Multiple assays used with ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur CP Systems: Theophylline 2, Procalcitonin, Folate, DHEA-SO4, CA 19-9, BR Assay for CA 15-3, BR Assay for CA 27.29, BNP (B-type Natriuretic Peptide), In vitro diagnostic medical devices (IVDs) 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-2012-RN-01135-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-11-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01135-1
  • 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
    The operating range of the advia centaur systems is 18°c to 30°c. the affected assays can product inaccurate results when performed within this operating range. a change in room temperature may increase or decrease assay results, depending on the specific assay and advia centaur system used.This phenomenon is observed when assay results are reported at a temperature different from the temperature at which the assay was calibrated. depending on the frequency of quality control testing and laboratory temperature at the time quality controls are tested, this issue may not always be detected through routine quality control monitoring.
  • 조치
    Customers are being advised to immediately implement the revised room temperature operating ranges for the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur CP assays

Device

Multiple assays used with ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur CP Systems: Theophylline...
  • 모델명 / 제조번호(시리얼번호)
    Multiple assays used with ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur CP Systems: Theophylline 2, Procalcitonin, Folate, DHEA-SO4, CA 19-9, BR Assay for CA 15-3, BR Assay for CA 27.29, BNP (B-type Natriuretic Peptide), In vitro diagnostic medical devices (IVDs)Theophylline 2ARTG: 175699Procalcitonin, DHEA-SO4ARTG: 175698FolateARTG: 175700BR Assay for CA 15-3, CA 19-9, BR Assay for CA 27.29ARTG: 175636BNPARTG: 175075Multiple SN and REF Numbers
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division