Events

MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for SelfTesting & MultiPa 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nipro Diagnostics, 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
    67152
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0909-2014
  • 사례 시작날짜
    2013-10-02
  • 사례 출판 날짜
    2014-02-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-01-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124790
  • 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
    Manufactured with an incorrect factory set unit of measure.
  • 조치
    Nipro Diagnostics sent an Urgent Medical Device Voluntary Recall letter dated December 31, 2013 to all affected customers. The customers were instructed to do the following: 1) Screen their inventory immediately for any of the serial numbers listed on the back of the products. 2) If they have any of the affected products, return the product by contacting Stericycle at 1-866-236-4518. 3) Complete and return the enclosed response form via fax at 1-888-358-7294. Customers with questions were instructed to call Stericycle at 1-866-236-4518. For questions regarding this recall call 954-677-9201.

Device

MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for SelfTesting & MultiPa
  • 모델명 / 제조번호(시리얼번호)
    Finished Good: KK0468; Lot Numbers: KL01079, KM0337TI, KN1834TI, KN1973TI, KN2074TI, KN 2089TI, KN2090TI, KN2102TI, KP0047TI, KP0076TI, KP0128TI, KP0925TI.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide, HI and Puerto Rico and Internationally to Canada, European Union, Jamaica, Suriname, Trinidad and Tobago, Kazakhastan, Russian, Turkey, Australia, Bangladesh, Pakistan, Cambodia, Laos, Myanmar, Thailand, Vietnam, and India.
  • 제품 설명
    MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. || Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm.
  • Manufacturer
    Nipro Diagnostics, Inc.

Manufacturer

Nipro Diagnostics, Inc.
  • 제조사 주소
    Nipro Diagnostics, Inc., 2400 NW 55th Ct, Ft Lauderdale FL 33309-2672
  • 제조사 모회사 (2017)
    Nipro Corporation
  • Source
    USFDA