Events

Device Recall VITROS 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
    61409
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1470-2012
  • 사례 시작날짜
    2012-03-15
  • 사례 출판 날짜
    2012-04-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-09-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108021
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • 원인
    Ortho-clinical diagnostics is recalling vitros chemistry systems due to possible internal hard drive failure.
  • 조치
    Ortho Clinical Diagnostics (OCD) sent an Important Product Correction Notification letter dated March 15, 2012 via FedEx overnight courier to all affected customers. Foreign affiliates were informed by email on 15 March 2012 of the issue and instructed to notify their consignees of the issue and actions. The letter identified the affected products, problem and actions to be taken. The letter instructed customers to: 1) Consider performing the backup procedure more frequently to help prevent the loss of data on your system; 2) Contact OCD Customer Technical Service representatives if a hard drive failure occurs on your system; A Field Engineer will be dispatched to replace the hard drive on your system; 3) Complete and return the Confirmation of Receipt form upon receipt of this notification; and 4) Post this notification by each VITROS¿ System in your facility or with the user documentation. For questions, refer to the Questions and Answers section. For additional questions, contact Customer Technical Services at 1-800-421-3311.

Device

Device Recall VITROS
  • 모델명 / 제조번호(시리얼번호)
    Serial number range: 56001033 - 56001449
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    VITROS® 5600 Chemistry System, Product Code: 6802413 || Product Usage: || For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

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