Events

VITROS CKMB 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
    64901
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1337-2013
  • 사례 시작날짜
    2013-04-03
  • 사례 출판 날짜
    2013-05-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117358
  • 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
    Calibrator, multi-analyte mixture - Product Code JIX
  • 원인
    Internal testing demonstrated that opened-reconstituted vitros ck-mb calibrators stored at -20 degrees celsius (-4 degrees farenheit) generated invalid calibrations that were detected by positively biased quality control results.
  • 조치
    Ortho Clinical Diagnostic sent a " Important Product Correction Notification" letter dated April 3, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were informed of the issue and advised they must discontinue storage of opened-reconstituted vials of VITROS CK-MB Calibrators frozen at -20 degrees Celsius (-4 degrees Farenheit). The same day, the Distributor letters were sent via US Postal Service Priority Mail or FedEx overnight courier to US Distributor consignees who were informed of the issue and instructed to notify their customers of the issue and actions. Also on April 3, 2013, the foreign affiliates were informed of the issue by e-mail and instructed to notify their consignees of the issue and actions. Confirmation of Receipt - Important Response Required so that we can complete our records, please return this form to us no later than April 19, 2013. FAX: 1-888-557-3759 or 1-585-453-4110 We apologize for any inconvenience this may have caused your laboratory. If you have any additional questions, please call Customer Technical Services at 1-800-421-3311.

Device

VITROS CKMB Calibrators
  • 모델명 / 제조번호(시리얼번호)
    Lots 1400 (exp. 22 April 2013), 1410 (exp. 20 May 2013), 1420 (exp. 12 July 2013), 1430 (exp. 5 August 2013) , 1440 (exp. 10 September 2013), 1450 (exp. 18 November 2013), 1460 (exp. 18 November 2013), 1465 (exp. 13 November 2013), 1480 (exp. 3 January 2014)
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - Nationwide including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
  • 제품 설명
    VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK || For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of CK-MB 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