Events

cobas 4800 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Roche Molecular Systems, Inc. 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
    64930
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1346-2013
  • 사례 시작날짜
    2013-04-01
  • 사례 출판 날짜
    2013-05-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-08-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117447
  • 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
    real time Nucleic acid amplification system - Product Code OOI
  • 원인
    In rare instances, channel shifted results have been generated with cobas¿ 4800 assays run on v1.1.1 of the cobas¿ 4800 system. raw data review indicates that, in these cases, all signals are shifted by one channel: channel 1 results report as channel 2, channel 2 results report as channel 3, channel 3 results report as channel 4, and channel 4 results report as channel 1. in the reported.
  • 조치
    Roche sent an "Urgent Medical Device Correction" (UMDC) notification with response form dated April 1, 2013, to all affected customers via UPS Ground on April 1, 2013. The letter identified the product, the problem, and the action to be taken by the customer. A contact number (Roche Diagnostic Technical Support) is provided for technical support 24 hours a day, seven days a week at phone number: 1-888-912-7090.

Device

cobas 4800
  • 모델명 / 제조번호(시리얼번호)
    Material Number 05200881001 - all lot/serial numbers.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    cobas¿ 4800 system z480 instrument. || Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
  • Manufacturer
    Roche Molecular Systems, Inc.

Manufacturer

Roche Molecular Systems, Inc.
  • 제조사 주소
    Roche Molecular Systems, Inc., 1080 Us Highway 202 S, Branchburg NJ 08876-3733
  • 제조사 모회사 (2017)
    Roche Holding AG
  • Source
    USFDA