Events

Device Recall Instrument Manager software 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Data Innovations, 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
    52105
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0083-2012
  • 사례 시작날짜
    2009-05-11
  • 사례 출판 날짜
    2011-10-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-10-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82110
  • 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 "previous result" retrieved from the specimen management database may not be the most recent "previous result".
  • 조치
    Data Innovations sent an "IMPORTANT PRODUCT NOTICE" dated May 11, 2009 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter offers temporary workarounds for customers to use until corrected versions of the software is complete. Versions of the corrections will be provided on a staggered schedule. Customers will be notified by e-mail. Questions regarding this notice are directed to Support at 802-658-1955.

Device

Device Recall Instrument Manager software
  • 모델명 / 제조번호(시리얼번호)
    S/W Versions 8.05, 8.06, 8.07, 8.08 and 8.09.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    USA (nationwide) and the country of Canada.
  • 제품 설명
    Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. || It is a stand-alone software package that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. The Instrument Manager software is put on a CD which is distributed in a box. User documentation consists of user manuals, PDF copies of which are on the CD Intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
  • Manufacturer
    Data Innovations, Inc.

Manufacturer

Data Innovations, Inc.
  • 제조사 주소
    Data Innovations, Inc., 120 Kimball Ave Ste 100, South Burlington VT 05403-6837
  • Source
    USFDA