Events

Device Recall Assay for CA 27.29 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
    76766
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1749-2017
  • 사례 시작날짜
    2017-03-08
  • 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=154129
  • 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, immunological, antigen, tumor - Product Code MOI
  • 원인
    Potential for the advia centaur syphilis assay to interfere with the br (ca 27.29) a assay on the advia centaur systems.
  • 조치
    Siemens Healthcare issued An Urgent Medical Device Correction (UMDC) to customers in the United States on March 08, 2017 to be delivered to customers on March 09, 2017and (UFSN) was sent for distribution to customers outside the United States on March 08, 2017. These notices inform customers of the potential and mitigation action to be taken for the ADVIA Centaur¿ Syphilis assay to interfere with the BR (CA 27.29) assay on the ADVIA Centaur Systems. This issue affects all current and future lots of ADVIA Centaur¿ Systems BR reagents until a solution is implemented. Fax-back forms included with letter used to confirm that the customers received the Urgent Medical Device Correction to the Customer Care Center at 312-275-7795. For questions regarding this recall call 508-668-5000. .

Device

Device Recall Assay for CA 27.29
  • 모델명 / 제조번호(시리얼번호)
    All lot codes
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nationwide) Internationally to Australia, Brazil, Canada, Columbia, Cyprus, Japan, Spain
  • 제품 설명
    Siemens ADVIA Centaur BR assay || Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) || BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, ADVIA Centaur¿ XP, and ADVIA Centaur¿ XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.
  • 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