Events

VITROS 4600 Chemistry System (VITROS 5, FS System family member)VITROS 5600 Integrated System 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
    69727
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1004-2015
  • 사례 출판 날짜
    2015-01-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131433
  • 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
    Calibration may not occur when using calibrator barcode labels supplied with vitros chemisty products calibrator kit 2.
  • 조치
    Ortho Clinical Diagnostics sent an Important Product Correction Notification letter dated September 29, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2. The resolution to this software anomaly will be in a future version of software. Until the new software is installed on their VITROS¿ System, customers were instructed not to use the calibrator barcode labels for VITROS¿ Calibrator Kit 2. Customers were advised that you manually program the calibration. Customers with questions were instructed to contact Customer Technical Services at 1-800-421-3311.

Device

VITROS 4600 Chemistry System (VITROS 5, FS System family member)VITROS 5600 Integrated System
  • 모델명 / 제조번호(시리얼번호)
    System Product Code: 1) 6802445, 2) 6802413
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including CO, NC, NJ, NY, PA, MI, WV and Internationally to Canada, Japan and Spain.
  • 제품 설명
    VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System || 1) VITROS 4600 - in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 - in vitro quantitative, semi-quantitative, and qualitative measurement of analytes
  • 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