Events

VITROS Immunodiagnostic Products CA 125 II Calibrators 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ortho-Clinical Diagnostics 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
    66496
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0525-2014
  • 사례 시작날짜
    2013-10-09
  • 사례 출판 날짜
    2013-12-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-05-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122496
  • 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
    Test, epithelial ovarian tumor-associated antigen (ca125) - Product Code LTK
  • 원인
    Ortho clinical diagnostics issued a product correction notification for vitros immunodiagnostic products ca 125 ii reagent pack and calibrators due to a positive shift in patient results.
  • 조치
    The firm, Ortho Clinical Diagnostics, sent a "IMPORTANT PRODUCT CORRECTION NOTIFICATION" letter dated October 9, 2013 to their clients/customers informing them of a shift in results that may be observed when performing patient sample correlation tests between VITROS CA 125 II Calibrators and Reagent Packs. The letter described the product, problem and actions to be taken. The customers were informed that it is acceptable to continue using any remaining inventory until its expiration date providing that quality control results are within acceptable limits (Note: Lots 1220 and 1230 are expired). The customers were also instructed to consider the need to review patient results using the affected lot(s). If you suspect that a previously reported result may have been affected, provide this information to your Laboratory Medical Director and the requesting physician or health care provider so that appropriate actions may be taken for the patients; Complete and return the attached Confirmation of Receipt form no later than October 18, 2013 via FAX TO: Ortho Clinical Diagnostics at 1-888-557-3759 or 1-585-453-4110, and Forward the information in this notification if you have distributed this product outside of your facility. If you have any additional questions, please contact Customer Technical Services at 1-800-421-3311.

Device

VITROS Immunodiagnostic Products CA 125 II Calibrators
  • 모델명 / 제조번호(시리얼번호)
    product code: 680 0034; Lot numbers 1220, 1230, 1240, 1250
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) including states of: AK, CA, CT, CO, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV, WY, and Puerto Rico, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.
  • 제품 설명
    VITROS CA 125 II Calibrators || For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of OC 125 defined antigen in human serum and plasma (EDTA or heparin).
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • 제조사 주소
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • 제조사 모회사 (2017)
    The Carlyle Group LP
  • Source
    USFDA