Events

Device Recall ADVIA Centaur CA199 Assay 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare Diagnostics, Inc 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
    60502
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0489-2012
  • 사례 시작날짜
    2011-11-11
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-04-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105596
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    System, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer - Product Code NIG
  • 원인
    Positive bias of 14% and higher for some individual points for ca 19-9 results generated on the advia centaur cp system when they are compared to ca 19-9 assay results generated on either the advia centaur or advia centaur xp systems.
  • 조치
    Siemens Healthcare Diagnostics issued a Urgent Device Notification email dated November 11, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed the customers conduct a look back if they are using the ADVIA Centaur CA 19-9 interchangeably with the ADVIA Centaur or ADVIA Centaur XP systems and the ADVIA Centaur CP system and to review the contents of the recall notice with their Laboratory Director. A confirmation fax-back form is included to ensure that all customers worldwide have been notified and have complied with the mandatory action For further questions please call (508) 359.3825.

Device

Device Recall ADVIA Centaur CA199 Assay
  • 모델명 / 제조번호(시리얼번호)
    Reagent Lot # Expiry Date XXXXX294 11-Aug-11 XXXXX296 6-Oct-11 XXXXX298 6-Nov-11 XXXXX299 6-Nov-11 XXXXX302 9-Jan-12 XXXXX303 9-Jan-12 XXXXX305 18-Feb-12 XXXXX306 3-Apr-12 XXXXX307 3-Apr-12 XXXXX308 3-Apr-12 XXXXX309 3-Jun-12 XXXXX311 30-Jun-12
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) and the countries of Australia, Malyasia, Korea, Hong Kong, Singapore, Myanmar, Mexico, Egypt, Taiwan, South Africa, Brazil ,India, Japan, Argentina, Chile, Peru, Germany, Malaysia, Saudi Arabia, and Canada.
  • 제품 설명
    ADVIA Centaur CA19-9 Assay || Cat. Nos. || 123521 (03481938) - 250 Test kit w/o Calibrators || 123519 (04612750) - 50 Test kit w/o Calibrators || 10491244 - 250 Test kit w/Calibrators || 10491379 - 50 Test kit w/Calibrators || The ADVIA Centaur CA 19-9 Assay is an¿ in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum CA 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort. CA 19-9 values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is determined.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc

Manufacturer

Siemens Healthcare Diagnostics, Inc
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA