Events

Aquios CL Flow Cytometer 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
    75111
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2900-2016
  • 사례 시작날짜
    2016-09-06
  • 사례 출판 날짜
    2016-09-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-08-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149377
  • 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
    Flow cytometric reagents and accessories. - Product Code OYE
  • 원인
    Beckman coulter is recalling the aquios cl system because the use of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe.
  • 조치
    An Urgent Medical Device Recall letter dated 9/6/16 was sent to customers to inform them that the use of Positions 9 and 10 of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe. The letter informs the customers of the impact of the recall, action to be taken, and the resolution by Beckman Coulter. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding this notice, are instructed to contact Customer Support Center: http://www.beckmancoulter.com/customersupport/support; call 1-800-369-0333 in the US and Canada; outside the US and Canada, contact their local Beckman Coulter Representative.

Device

Aquios CL Flow Cytometer
  • 모델명 / 제조번호(시리얼번호)
    AY20032 AZ19046 AZ12030 AY51072 AZ19047 AZ15044 AY47071 AZ15038 AY47063 AZ12033 AZ19052 AY51075 AY03004 AZ12027 AY25038
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US: IL, PA, NY, GA, WA, FL, SC. Affected geographies: Angola, Australia, Belgium, Botswana, Canada, Chile, Columbia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Israel, Italy, Malaysia, Nambia, Netherlands, Panama, Poland, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Uganda, United Kingdom and Zambia
  • 제품 설명
    AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.
  • 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