Events

Siemens Healthcare ADVIA Centaur systems Calibrator B for FSH 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
    62897
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2410-2012
  • 사례 시작날짜
    2012-08-07
  • 사례 출판 날짜
    2012-09-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-02-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112142
  • 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
    Siemens Healthcare - Product Code CGJ
  • 원인
    Advia centaur prolactin assay and fsh, calibrator b fails the analytical sensitivity stated in the ifu for lots below 40.
  • 조치
    Siemens Healthcare issued an Urgent Field Safety Notice letter dated August 2012 by e-mail to all affected Siemens Healthcare Diagnostics Branch offices on August 7, 2012. Customers were instructed to discontinue using the ADVIA Centaur Calibrator B lots 40 and below following their obtaining Calibrator 8 lot 41 or higher. Customers were asked to complete and fax-back the response form attached.

Device

Siemens Healthcare ADVIA Centaur systems Calibrator B for FSH
  • 모델명 / 제조번호(시리얼번호)
    US: 2 Pack Ref: 00649625: Lot Numbers/Exp Date: Dec 2, 2012: 78813A30 79982A30 81013A30 82021B30 82767B30 83453C30 85447D30 87319A40 Exp Date:April 9, 2013 85598A40 85708A40 86098A40 87319A40 87979B40 88809B40 89351C40 91750C40 (6 pack) Ref. 00652707: Lot Numbers/Exp Date: Dec 2 2012 79354A30 80802A30 81892B30 82815B30 83741D30 84186A40 Exp. Date April, 8, 2013 85599A40 86191A40 88102B40 89717C40 91383C40 (6 Pack) Ref: 00654254  79714A30 Exp Date Dec 2, 2012 82370A30 84274A30 85512E30 OUS: 2 pack REF: 00650577  78319A29 Exp Dec 2, 2102 78487A29 79024A29 79403A29 79770B29 79981B29 82935B29 85735C29 00654130  Ref: 00654130 (6 pack) 78321A29 Exp Dec 2,2102 79197A29 83314C29
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of: Canada, Argentina, Australia, Bangaldesh,Brazil, Chile, China, Columbia, Croatia, Ecuduar, Egypt, Hong Kong, India, Israel,Japan, Korea, Maylasia, New Zealand, Mexico, Peru, Philipines, Pakistan, Saudia Arabia, Singapore, Thailand, Taiwan, Viet Nam, South Africa and UK.
  • 제품 설명
    ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B || US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) || OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) || Product Usage: || ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems
  • 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