Events

CELLDYN Emerald 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
    57202
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1094-2011
  • 사례 시작날짜
    2010-10-15
  • 사례 출판 날짜
    2011-02-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-06-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95590
  • 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
    There is the potential for the instrument to not power up due to the flash memory issue. this will result in an error message displayed is "no memory available" and has the potential for delay in generating patient results.
  • 조치
    The firm, Abbott Laboratories, sent a "Product Correction" letter dated October 15, 2010 to all customers. The letter described the product, problem and action to be taken by the customer. The customers were instructed to install a new printer driver in the software location using the provided instructions and to complete and return the Customer Reply Form via fax 1-800-777-0051 or email to QAGCO@abbott.com even if they no longer have the instrument. If you have any questions regarding this information, U.S. customers should call Customer Support at 1-877-4ABBOTT; customers outside the U.S., please contact your local hematology customer support representative.

Device

CELLDYN Emerald
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers ending in  0063,0110,0196,0197,  0230,0281,0285,0293,  0319,0329,0332,0358,  0361,0362,0396,0435,  0440,0468,0474,0606,  0642, 0664, 0687, and  0719 through 1331
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, O, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WI; and countries including: Argentina, Australia, Brazil, Canada, Dominican Republic, Germany, Singapore, South Korea, St. Eustalius & St. Martin, Trinidad and Tobago.
  • 제품 설명
    Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; || List Number: 09H39-01; Field Replaceable Unit (FRU) Numbers: 8701686901, 8701686902; || Product is distributed by || Abbott Diagnostics Division, Santa Clara. CA and manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, IL || Intended use: 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