Events

Device Recall UniStrip1 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Unistrip Technologies LLC 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
    69856
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0855-2015
  • 사례 시작날짜
    2014-11-20
  • 사례 출판 날짜
    2014-12-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-05-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131711
  • 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
    Failure to submit a 510(k) for device labeling changes.
  • 조치
    UniStrip Technologies sent an Urgent Device Recall letter dated November 20, 2014, to all affected customers. They were instructed to immediately inform any of their retail accounts of the recall and have them return any of the recalled product to the distributor. The product is then to be returned to Unistrip Technologies. A reply form was included to be completed by the retail accounts and returned to the distributor who would in turn return the form to Unistrip Technologies to track returns. If you have any further questions, please call 1-866-861-8066.

Device

Device Recall UniStrip1
  • 모델명 / 제조번호(시리얼번호)
    U14030713, 814031313, U140312323, and U14031413.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of FL and OH.
  • 제품 설명
    UniStrip1, Blood Glucose Test Strips, 50 count box. || The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
  • Manufacturer
    Unistrip Technologies LLC

Manufacturer

Unistrip Technologies LLC
  • 제조사 주소
    Unistrip Technologies LLC, 301 Mccullough Dr, Suite 400, Charlotte NC 28262-3310
  • 제조사 모회사 (2017)
    Unistrip Technologies Llc
  • Source
    USFDA