Events

Device Recall COULTER DxH Cell Lyse 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
    59726
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3263-2011
  • 사례 시작날짜
    2011-07-11
  • 사례 출판 날짜
    2011-09-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103461
  • 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
    Products, red-cell lysing products - Product Code GGK
  • 원인
    The recall was initiated because beckman coulter identified unexpected high particle counts in the lots of dxh cell lyse listed. these lots may generate high background counts; could result in a falsely elevated total nucleated count (tnc) of up to 50 cells/¿l; or may also result in recovery of tnc values that were higher than expected for level 1 of the body fluid control.
  • 조치
    The recall communication was initiated on 08/01/2011 with Beckman Coulter forwarding a Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US customers) to all customers, who purchased Coulter DxH Cell Lyse. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to contact Beckman Coulter for product replacement. In addition, customers were instructed to complete and return the enclosed PCA Response Form within 10 days. Customers with questions regarding this Product Corrective Action were instructed to call Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their Beckman Coulter representative.

Device

Device Recall COULTER DxH Cell Lyse
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 0710001, 0710003, 0711002, 0712001, 0710002, 0710004, 0711001, 0711003, and  0712002.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- Australia, Belgium, Brunei Darussalam, Canada, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Philippines, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and the United States.
  • 제품 설명
    COULTER DxH Cell Lyse, Part number 628018(1L) and 628019 (5L). || The COULTER¿ DxH Cell Lyse is an erythrocyte lytic agent used for quantitative || determination of hemoglobin, enumeration of NRBC, and counting and sizing || leukocytes on UniCel¿ DxH 800 Coulter¿ Cellular Analysis System.
  • 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