Events

Device Recall CELLDYN Emerald Hematology Analyzer System 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
    55146
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1733-2011
  • 사례 시작날짜
    2010-03-23
  • 사례 출판 날짜
    2011-03-18
  • 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=90074
  • 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
    Abbott has determined that gain settings for the non-standard specimen types may not match the gain settings for the standard specimen type. there is the potential for impact to product performance.
  • 조치
    The firm, Abbott, sent two "Product Correction" letters one dated March 23,2010 and a follow-up letter dated July 1, 2010, via express mail to all its consignees/customers. The letters described the product, problem and actions to be taken. The customers were instructed to perform the following steps, noted in the letter, to print and verify their gain setting. Abbott informed the customers that they would receive a mandatory software update and were instructed to install the CELL-DYN Emerald according to the attached instructions, and to complete and return the Customer Reply form via fax to 1-800-777-0051 or email to QAGCO@abbott.com. Should you have any questions or would like to discuss in more detail, contact Director Quality Assurance and Regulatory Affairs Abbott Hematology at 408-567-3403.

Device

Device Recall CELLDYN Emerald Hematology Analyzer System
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, and WV; and countries including: Australia, Brazil, Canada, Columbia, Dominican Republic, Germany, Puerto Rico, Singapore, South Korea, St. Eustalius & St. Martin, and Turks & Caicos.
  • 제품 설명
    Abbott brand CELL-DYN Emerald Hematology Analyzer System; List Numbers: 09H39-01; The product is manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, IL || The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.
  • Manufacturer
    Abbott Laboratories

Manufacturer

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