Events

Device Recall 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
    73429
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1348-2016
  • 사례 시작날짜
    2016-02-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-05-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144194
  • 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
    The two sets of wires (4 total wires) exiting from the emi filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated ac power cord is unplugged.
  • 조치
    On February 16, 2016, Ortho Clinical Diagnostics distributed Urgent Product Correction Notification notices to their customers via FedEx overnight courier, e-communications and via USPS. Customers are advised that there is no impact to the results generated with an affected system. As a precaution, your Ortho-trained service representative will contact you to schedule an inspection of the wiring within the system at your facility. Following the inspection, reconfiguration of the wiring on your system will be performed if appropriate. Please store a copy of the notification with your user documentation until the wires within your system(s) are inspected. In addition, complete the receipt form to indicate that you have been informed of this anomaly. Please return the form to Joe Falvo via email at confirmationadmin@its.jnj.com or via fax to 1-888-557-3759 or 1-585-453-4110. Customers with questions can contact the Technical Solutions Center at 1-800-421-3311 anytime.

Device

Device Recall VITROS 5600 Integrated System
  • 모델명 / 제조번호(시리얼번호)
    Product Codes: 6802413, 6802915 (Refurbished) Serial numbers: J56000024 - J56002387
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.
  • 제품 설명
    VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. || Intended for use in the in vitro measurement of a variety of analytes of clinical interest.
  • 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