Events

ADVIA Chemistry Systems A1c_3 Calibrators 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare Diagnostics 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
    68871
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2643-2014
  • 사례 시작날짜
    2014-08-06
  • 사례 출판 날짜
    2014-09-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128896
  • 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
    Calibrator, multi-analyte mixture - Product Code JIX
  • 원인
    The advia chemistry systems a1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (hb)a1c samples when using a1c_3 calibrator lots 3hd044 and 3ld068. depending on quality control limits, this issue may not have been detected. note: the percent bias range is a percentage of the hba1c result. it is not absolute hba1c units.
  • 조치
    Siemens sent an Urgent Field Safety Notice dated August 2014 to all affected consignees on August 6, 2014 via Federal Express. The letter instructed consignees to discontinue use and discard calibrator lots 3HD044 and 3LD068. Customers were requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within thirty (30) days. Distribution of the Urgent Field Safety Notices to foreign consignees was determined at the country level. For questions regarding this recall call 914-524-2955.

Device

ADVIA Chemistry Systems A1c_3 Calibrators
  • 모델명 / 제조번호(시리얼번호)
    Lots 3HD044 (exp. 11/01/2015), and 3LD068 (exp. 01/01/2016)
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Austria, Brazil, Canada, China, Colombia, Croatia, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, India, Indonesia, Istanbul, Italy, Lithuania, Mexico, Paraguay, Peru, Poland, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Korea, Spain, Switzerland, Thailand, Uruguay, Vietnam, and Zambia.
  • 제품 설명
    ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD || ADVIA Chemistry A1c_3 Calibrator Information: For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA Chemistry systems. || The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use.
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

Siemens Healthcare Diagnostics
  • 제조사 주소
    Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
  • Source
    USFDA