Events

Device Recall CELLDYN 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Laboratories 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
    54665
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1698-2011
  • 사례 시작날짜
    2009-11-30
  • 사례 출판 날짜
    2011-03-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-03-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88956
  • 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 use of the device assemblies has been extended to a 6 month useful life.
  • 조치
    The firm, Abbott Laboratories, sent a "Product Correction" letter dated November 30, 2009 to all consignees/customers. The letter described the product, problem and actions to be taken. The letter stated that Abbott recommended that the customers change their Waste Line Assembly and Waste Outlet Tubing every six months and included a tag in the letter to record installation and replacement dates. Additionally, the customers were instructed to keep this communication with their CELL-DYN System Operator's Manual and complete and return the Customer Reply form via fax to 1-800-777-0051 or email QAGCO@abbott.com even if they no longer have the instrument. If you have any questions regarding this communication, U.S. customers should call Customer Support at 1-877-4ABBOTT (1-877-422-2688). Customers outside the U.S. please contact your local hematology customer support representative.

Device

Device Recall CELLDYN
  • 모델명 / 제조번호(시리얼번호)
    Model Numbers: 92161-02 and 06H54-01 for the Waste Line Assembly; 02H96-01 for the Waste Outlet Tubing; and 03H98-02 for the Waste Bottle Cable.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: AL, AR, AZ, CA. CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO MS, MT , NC, NE, NJ, NM, NY, OH, OK, PA, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and countries including: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Dominican Republic, Germany, Guatemala, Hong Kong, Japan, Mexico, New Zealand, Panama, Peru, Puerto Rico, Singapore, South Korea, Thailand, Trinidad and Tobago, and Uruguay.
  • 제품 설명
    The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are components that are used on one or more CELL-DYN Systems. || Usage: Accessories to human waste container systems
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • 제조사 주소
    Abbott Laboratories, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • Source
    USFDA