Events

Siemens ADVIA Centaur CA 199 Assay (250 test kit) 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
    75523
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0613-2017
  • 사례 시작날짜
    2016-10-19
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150706
  • 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
    Ca 19-9 assay on the advia centaur cp does not meet the correlation to the ca 19-9 assay on the advia centaur/xp/xpt systems as stated in the instructions for use.
  • 조치
    Siemens Healthcare issued Urgent Medical Device Correction (UMDC) to Siemens Healthcare Diagnostics customers in the United States on October 19, 2016 to be delivered to customers on October 20, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on October 18, 2016. The notice informs the customer of the potential to observe a bias between CA 19-9 results generated on the ADVIA Centaur CP and the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems. Customers may continue to use the ADVIA Centaur CA 19-9 assay to report patient results on the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT and ADVIA Centaur CP systems. Customers should not use the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems interchangeably with the ADVIA Centaur CP when generating CA 19-9 results. For customers using the ADVIA Centaur CP and ADVIA Centaur/XP/XPT for CA 19-9 interchangeably, a look back of patient results over the previous three months is recommended. A Field Correction Effectiveness Check is to be completed, signed and returned Siemens. Questions, contact your Siemens Customer Care Center or your local Siemens technical support representative.

Device

Siemens ADVIA Centaur CA 199 Assay (250 test kit)
  • 모델명 / 제조번호(시리얼번호)
    Kit lots ending in:  380 Exp Date 2016-10-21;  382/ 2017-01-09; 384 2017-02-06; 386 2017-03-24 ; 388 2017-05-14 ; 390 2017-06-12 .  And all future lots until the issue is resolved. Siemens will also include a notecard in future lots of reagents referring customers to the communications.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Germany, Great Britain, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Latvia, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, Vatican City, Vietnam
  • 제품 설명
    ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. || Siemens Material Number(SMN): 10491244 || In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that the assay is being marketed on the XPT following FDAs Reagent Replacement Policy. Siemens plans to request CLIA Categorization for the CA19-9 assay on XPT the week of 11/21/2016.
  • 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