Device Recall VITROS (R) Chemistry Products FS Calibrator 1 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
    68286
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1805-2014
  • 사례 시작날짜
    2014-05-12
  • 사례 출판 날짜
    2014-06-16
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-03-23
  • 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
    Calibrators, drug mixture - Product Code DKB
  • 원인
    Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of european reference material (erm). the validation process was not complete prior to calibrator value assignment for vitros (r) chemistry products hscrp reagent (product code 6801739), generation (gen) 28.
  • 조치
    Customer Product Correction Letters (CL2014-143, dated 5/12/14) were sent on 5/12/2014 via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) and /or ORTHO PLUS e-Communications to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them to discontinue use of the affected calibrator lot(s), and inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. Distributor letter (DL2014-143) was also sent on 5/12/2014 via US Postal Service Priority Mail and/or FedEx overnight courier to US Distributor consignees and instructed to notify their consignees of the issue and the required actions. Foreign affiliates were pre-notified via e-mail on 5/08/2014 that the communication of this issue and required actions is imminent and were sent the finalized recall communication on 5/12/2014.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lots 91131 (exp. 07-Mar-2015) and 91241 (exp. 28-Feb-2016)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
  • 제품 설명
    VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only --- VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Ortho-Clinical Diagnostics, 1000 Lee Road, Rochester NY 14606
  • 제조사 모회사 (2017)
  • Source
    USFDA