Events

Device Recall SYNCHRON Gentamicin (GEN) Reagent 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Beckman Coulter 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
    53044
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2437-2010
  • 사례 시작날짜
    2009-02-19
  • 사례 출판 날짜
    2010-09-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84525
  • 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
    Enzyme immunoassay, gentamicin - Product Code LCD
  • 원인
    The reagent produces false low test results. beckman coulter has confirmed low recovery of values at the low end of the therapeutic range (<1.5 ug/ml, <3.13 umol/l) with synchron systems gentamicin reagent (gen) lot m804552. a false low result can cause a patient to receive more medication than necessary.
  • 조치
    Beckman Coulter sent an Urgent Product Corrective Action (PCA) letter dated February 27, 2009 to customers identifying the affected product and issue prompting the recall. The letter asked them to discontinue use and discard the reagent lot, and contact their Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada or contact their local Beckman Coulter Representative to discuss reagent replacement options. They were also asked to complete and return the enclosed response form within 10 days. Customers were directed to call the Customer Support Center (Hotline) at (800) 854-3633 in the US and Canada if they had questions in regards to the PCA letter. Outside the US and Canada they were told to contact their local Beckman Coulter Representative.

Device

Device Recall SYNCHRON Gentamicin (GEN) Reagent
  • 모델명 / 제조번호(시리얼번호)
    Lot Number M804552
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV, and countries of Canada, Belgium, Denmark, France, Germany, Ireland, Lithuania, Netherlands, Spain, Switzerland, United Kingdom, New Zealand, Singapore, Egypt, South Africa, Taiwan, and United Arab Imarets.
  • 제품 설명
    SYNCHRON Gentamicin (GEN) Reagent || GEN reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 3 Plus, is intended for quantitative determination of Gentamicin concentration in
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • 제조사 주소
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA