Events

Device Recall EpiCenter Plus Microbiology Data Management System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Becton Dickinson & Co. 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
    76498
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1414-2017
  • 사례 시작날짜
    2014-08-25
  • 사례 출판 날짜
    2017-02-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153374
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • 원인
    The information in the epicenter interface translation tables was not updated to match the bruker maldi biotyper database identifications for some organisms. this could lead to a possible mis-identification of an organism.
  • 조치
    Customers were initially contacted via phone calls and subsequently provided with a written communication. For questions contact BD Technical Services Department at 1-800-638-8663.

Device

Device Recall EpiCenter Plus Microbiology Data Management System
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers Version 6.20A  Cat. Number 442953
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    15 US customers, 18 Ex-US sites, and 0 distributors. Approximately 115 customers totally and 0 distributors
  • 제품 설명
    EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . || Product Usage: || The EpiCenter system is a clinical data management system designed for use with certain BD instrument systems. The EpiCenter system provides advanced capabilities in data management, including extended demographic data, comprehensive reporting features including a powerful database query tool, bi-directional Laboratory Information System (LIS) communications and long-term data storage. Additionally, the EpiCenter system provides an Expert System that can manipulate and/or act upon AST results.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • 제조사 주소
    Becton Dickinson & Co., 7 Loveton Cir, BD Diagnostic Systems, Sparks MD 21152-9212
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA