Events

Device Recall Beckman Coulter Slidemaker Stainer 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
    77778
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3101-2017
  • 사례 시작날짜
    2017-06-20
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157861
  • 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
    Counter, differential cell - Product Code GKZ
  • 원인
    The firm has identified that a fitting in some slidemaker stainer units may not completely seal after installation.
  • 조치
    Beckman Coulter sent an Urgent Medical Device Recall letter dated June 20, 2017. The notification advised consignees to immediately contact a Beckman Coulter representative if a leak is observed to schedule a service, to inspect reagent supply drawer for spills, and to follow best laboratory practices when using the device (including Personal Protective Equipment). Beckman Coulter indicates that the issue will be resolved with the replacement of the correct fitting on all impacted instruments. Labs were advised to notify all staff of the recall and to retain the notification. They were also instructed to forward the recall notice to all customers, if any product was further distributed, and to complete and return the Customer Response form within ten days of receiving the recall notification. Completed forms are to be sent back to the firm via email to Regulatory.Notifications@beckmancoulter.com. Regulatory Affairs Mail Code 31-B06. Questions can be directed to beckmancoulter.com or 800-526-7694. Consignees outside of the US are advised to contact their Beckman Coulter representative in the case that questions do arise.

Device

Device Recall Beckman Coulter Slidemaker Stainer
  • 모델명 / 제조번호(시리얼번호)
    P/N A85371AA20; Catalog No. 775222
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, and WV., and to the countries of : Australia, Brazil, Canada, Chile, China, Czech Republic, Denmark, France, Greece, Hong Kong, India, Israel, Italy, Japan, Morocco, Portugal, South Korea, South Africa, Spain, Taiwan, Turkey, United Kingdom, Vietnam, and Switzerland.
  • 제품 설명
    UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. || The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. || Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: Allows for the differentiation of white blood cells, facilitates the characterization of red blood cells and platelets, and aids in the identification of blood components and cellular abnormalities.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • 제조사 주소
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA