Events

FreeStyle InsuLinx 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
    64876
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1245-2013
  • 사례 시작날짜
    2013-04-15
  • 사례 출판 날짜
    2013-05-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-08-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117228
  • 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
    At rare, extremely high glucose levels (1024 mg/dl and above), the freestyle insulinx blood glucose meter may provide an inaccurate reading.
  • 조치
    Abbott Diabetes Care sent an Urgent Product Recall letter dated April 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take one of the following options immediately to address the issue. 1) Customers can access a software update to resolve the issue at www.freestyleinsulinx.com/swupdate. 2) Customers can contact Abbott Diabetes Care Customers Service at 1-866-723-2697 to expedite return and replacement of the affected product at no charge. For questions customers were instructed to call Abbott Diabetes Care Customers Service at 1-866-723-2697. For questions regarding this recall call 510-239-2775.

Device

FreeStyle InsuLinx Blood Glucose Monitoring System
  • 모델명 / 제조번호(시리얼번호)
    Part Numbers: 71142-70 71143-70 71145-70 71150-70: All serial and lot numbers.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    FreeStyle InsuLinx Blood Glucose Monitoring System: || For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. || Abbott Diabetes Care, Inc. || 1360 South Loop Road || Alameda, CA 94502 USA || The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
  • Manufacturer
    Abbott Diabetes Care, Inc.

Manufacturer

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