Access Total BhCG (BhCG) Assay 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Beckman Coulter 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
    57443
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1736-2011
  • 사례 시작날짜
    2010-10-20
  • 사례 출판 날짜
    2011-03-21
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-09-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Radioimmunoassay, human chorionic gonadotropin - Product Code JHI
  • 원인
    Beckman coulter has confirmed that non-reproducible falsely elevated test results may occur when using the access total bhcg assay. these elevated results are often attributed to pre-analytical factors and are particularly noted at the low end of the analytical measuring range. the role of preanalytical factors in laboratory testing has been described in a variety of published literature.
  • 조치
    Beckman Coulter sent an Urgent Product Corrective Action letter dated November 11, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:. " Evaluate current laboratory protocols to ensure the necessary procedures are in place for identifying and mitigating falsely elevated test results. " Follow the sample handling instructions provided in the Access Total ¿hCG Instruction for Use (IFU). " Review the enclosed pre-analytical sample handling information bulletins: 1. The Role of Preanalytical Factors in Chemistry and Immunoassay Testing (P/N A34880A). 2. Sample Handling Makes a Difference (P/N A28226A). " At the discretion of the laboratory director, any total ¿hCG result that is questioned due to lack of clinical correlation should be repeated. NOTE: Due to the clinical utility of the Access Total ¿hCG assay as a biomarker of pregnancy, Beckman Coulter feels it is unnecessary to require a review of all previously obtained Access Total ¿hCG test results. The Access Total ¿hCG assay is intended as a marker for pregnancy at the time of testing. A discrepant or questionable result would have been brought to the attention of the laboratory. The pregnancy status of a patient at this point, post testing, would be known to the patient and the physician. " Please share this information with your laboratory staff and your phlebotomy director and/or phlebotomy staff and retain this notification as part of your laboratory Quality System documentation. " Complete and return the enclosed response form within ten days so they can be assured that this important notification has been received. If you have any questions regarding this notification, please contact the Customer Support Center on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call 1-800-854-3633 in the United States and Canada. Outside the United States and Canada

Device

  • 모델명 / 제조번호(시리얼번호)
    All lot numbers
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Algeria, Angola, Antigua and Barbuda, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Congo, Croatia, Czech Republic, Djibouti, Egypt, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Zambia, Zimbabwe.
  • 제품 설명
    Access Total BhCG (BhCG) Assay Part Number 33500 || The Access Total BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • 제조사 모회사 (2017)
  • Source
    USFDA