Events

Advia Chemistry Systems Calibrator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare 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
    75487
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0589-2017
  • 사례 시작날짜
    2016-10-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-05-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150481
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • 원인
    Siemens has confirmed that the dbil_2 assigned calibrator values (acv) currently assigned to the affected lots may cause, on average, a positive proportional bias of approximately 41% on patient samples compared to the reference method for direct bilirubin measurement.
  • 조치
    Siemens issued an Urgent Medical Device Correction in the US and an Urgent Field Safety Notice Outside the US beginning on October 6, 2016. Customers were notified of the issue and instructed to use the reassigned DBIL_2 calibrator value for Chemistry Calibrator Lot Numbers 680726, 680726A, 680726B, 680726C and 680726D. Customers were also requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within 30 days by faxing to the Customer Care Center at 312-275-7795. For questions regarding this recall call 914-631-8000.

Device

Advia Chemistry Systems Calibrator
  • 모델명 / 제조번호(시리얼번호)
    Device Listing # D033650 Model# SMN# 10312279 Lot Numbers: 680726, 680726A, 680726B, 680726C, 680726D
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nationwide) Internationally to Canada, Mexico, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Chile, Cyprus, Denmark, Egypt, Ecuador, Finland, France, Germany, Great Britain, Hong Kong, Hungary, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Poland, Portugal, Russian Fed. Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, Vatican City and Vietnam
  • 제품 설명
    Advia Chemistry Calibrator || For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_2), Calcium (CA, CA_c, CA_2, CA_2c), Cholesterol (CHOL), Creatinine (CREA, CREA_2, CRE_2c, ECRE_2), Glucose Hexakinase (GLUH), Glucose Oxidase (GLUO), Iron (IRON_2), Lithium (LITH), Magnesium (MG, MG_c), Phosphorus - inorganic (IP, IP_c), Total Protein (TP, TP_c), Triglycerides (TRIG), Urea Nitrogen (UN, UN_c), Uric Acid (UA, UA_c)
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA