Events

Device Recall HemoCue Urine Albumin Microcuvettes 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 HemoCue AB 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
    65918
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0086-2014
  • 사례 시작날짜
    2013-07-16
  • 사례 출판 날짜
    2013-10-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-04-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120865
  • 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
    Automated urinalysis system - Product Code KQO
  • 원인
    Hemocue ab has become aware of a production related problem involving punctured hemocue¿ urine albumin microcuvettes single pack pouches.
  • 조치
    HemoCue sent an Urgent Field Safety Notice dated July 24, 2013. to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to : 1. Quarantine any HemoCue¿ Urine Albumin (110608); lot numbers 1208848 to 1304847 you may have in your possession 2. Return the Field Safety Notice Verification Form to: fax: 562-668-5794 We apologize for the inconvenience this advisory has caused you. Please feel free to contact Technical Support at 800-426-7256 with any questions.

Device

Device Recall HemoCue Urine Albumin Microcuvettes
  • 모델명 / 제조번호(시리얼번호)
    Model Number 110608 Lot Number: 1210865, 1210873, 1211878, 1301893, 1302810, 1303836, 1304838, 1304840 and 1304842.  Model Number 110610 Lot Number: 1209857, 1210870, 1211874, 1211879, 1212885, 1301803, 1301893, 1302817 and 1302818.  Model Number 110611 Lot Number: 1208848, 1208853, 1208854, 1209855, 1209856, 1209858, 1209860, 1209862, 1210863, 1210865, 1210869, 1210871, 1210872, 1210873, 1211875, 1211876, 1211877, 1211880, 1211881, 1212884, 1212887, 1301802, 1301804, 1301805, 1301806, 1302811, 1302812, 1302813, 13028141302815, 1302816, 1302821, 1303823, 1303825, 1303834, 1304837, 1304839, 1304841, 1304843, 1304844, 1304845, 1304846 and 1304847.  Model Number 110613 Lot Number: 1303825  Model Number 110615 Lot Number: 1209858, 1211878  Model Number 110616 Lot Number: 1208849, 1208850, 1208851, 1210864, 1210866, 1210867, 1210868, 1210869, 1212883, 1212886, 1212888, 1212889, 1301807, 1301808, 1302809, 1303827, 1303829, 1303830, 1303831, 1303832 and 1303833.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - Nationwide Distribution including the states of AL, AR, AZ, CA, CA ,CT, FL, GA, HE, ID, IL, IN, LA, MA, ME, MI, MN, MO, MS, NC, NH, NM, NY, OH, PA, SC,TX, UT, VA, VT, WA and WI., and the countries of Australia, Bahrain, Belarus, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hong Kong, India, Indonesia, Italy, Kenya, Lesotho, Malawi, Mauritius, Mexico, Myanmar, Nigeria, Norway, Omen, Poland, Qatar, Romania, South Africa, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Ukraine, Yemen and Zambia.
  • 제품 설명
    HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden || The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes
  • Manufacturer
    HemoCue AB

Manufacturer

HemoCue AB
  • 제조사 주소
    HemoCue AB, Kuvettgaten 1, Angelholm Sweden
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA