Events

Device Recall Nova Max Glucose Test Strips 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nova Biomedical Corporation 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
    65617
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1906-2013
  • 사례 시작날짜
    2013-07-15
  • 사례 출판 날짜
    2013-08-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-08-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120660
  • 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
    System, test, blood glucose, over the counter - Product Code NBW
  • 원인
    Reports of false abnormally high glucose readings from test strips.
  • 조치
    Nova Biomedical U.S.A issued an Urgent Medical Device Voluntary Recall Letter dated July 19, 2013 via registered/certified letters to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately discontinue use of the affected product; contact Nova Diabetes Care Customer Service for replacement strips; do not stop testing blood glucose while waiting for replacement strips; if affected strips must be used follow precautions provided in notification letter. For questions call Nova Diabetes Care Customer Service at 1-800-681-7390. .

Device

Device Recall Nova Max Glucose Test Strips
  • 모델명 / 제조번호(시리얼번호)
    1010112059 12/31/2013 1010213171 04/30/2015 1010312066 12/31/2013 1010712339 10/31/2014
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
  • 제품 설명
    Nova Max Plus Monitor System (Kit w/10 Count Vials International) || Catalog Number: 45507 || Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control
  • Manufacturer
    Nova Biomedical Corporation

Manufacturer

Nova Biomedical Corporation
  • 제조사 주소
    Nova Biomedical Corporation, 200 Prospect St, Waltham MA 02453
  • 제조사 모회사 (2017)
    Nova Biomedical Corporation
  • Source
    USFDA