Freedom EVO2 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Tecan US, 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
    69369
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0149-2015
  • 사례 출판 날짜
    2014-10-29
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-07-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Station, pipetting and diluting, for clinical use - Product Code JQW
  • 원인
    Distortion (noise interference) of the liquid level capacitance can result in air aspiration instead of liquid aspiration. this might cause a false signal (air detection) with possible dispense errors resulting in erroneous results.
  • 조치
    Tecan sent an Urgent Field Corrective Action letter dated September 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Tecan has instructed field engineers to replace the ZAAP Motion Board in the Freedom EVO instrument. Your instrument was identified as affected and a Tecan Service Representative will contact you to arrange replacement of the board. Please make sure that your internal controls would detect any possible dispense errors that might affect your application when using the instrument before replacement of the board. Alternatively, stop using the instrument until the board is replaced. We apologize for any inconvenience this issue may have caused,and are implementing corrective and preventive actions to prevent recurrence. If you have any further questions, please contact your local Tecan Helpdesk for assistance. For further questions please call (919) 361-5200 ext. 19519

Device

  • 모델명 / 제조번호(시리얼번호)
    Part Number: 10641100, SN: 1407006311.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution to IL.
  • 제품 설명
    Freedom EVO-2 100 Base Unit, with Air LiHa Arms || The Freedom EVO is an open automation platform product for general laboratory use. It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Tecan US, Inc., 9401 Globe Center Drive, Suite 140, Morrisville NC 27560
  • 제조사 모회사 (2017)
  • Source
    USFDA