Events

Device Recall FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Diabetes Care, 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
    52427
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1936-2009
  • 사례 시작날짜
    2009-06-10
  • 사례 출판 날짜
    2009-09-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-01-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82937
  • 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
    Low results: freestyle lite blood glucose test strip may generate low blood glucose readings when tested with the control solution from lot 0822524 with freestyle freedom lite and freestyle lite blood glucose meters.
  • 조치
    An "Important: Medical Device Notification" letter dated June 10, 2009 was issued to consignees. First consignees received notifications via letters to both direct consignees and registered customers of FreeStyle Lite and FreeStyle Freedom Lite blood glucose meter users in the states where the affected test strip lot was distributed. Affected accounts and customers were instructed to discontinue distribution and use of the product. The notification will be posted to the Abbott Diabetes Care website. Direct questions about the recall to Abbott Diabetes Care, Inc. by calling 510-749-5400.

Device

Device Recall FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    Lot number 0822524, expiration date 2010/08.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US only (states AL, AZ, CA, FL, GA, IL, IN, MD, NJ, NY, OH, PA, RI, SC, TN, TX and WI).
  • 제품 설명
    FreeStyle Lite Blood Glucose Test Strips, CSP, 50's US, Checkpoint, FS Lite, for use with FreeStyle Lite Blood Glucose Meters and FreeStyle Freedom Lite Blood Glucose Meters, Part Number 70822-02, manufactured by Abbott Diabetes Care, Inc., Alameda, CA. || The product is used for testing outside the body (in vitro) diagnostic use, in the home and in professional settings to monitor blood glucose levels.
  • Manufacturer
    Abbott Diabetes Care, Inc.

Manufacturer

Abbott Diabetes Care, Inc.
  • 제조사 주소
    Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda CA 94502-7000
  • Source
    USFDA