Device Recall Infinite 200 PRO 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
    69739
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0992-2015
  • 사례 시작날짜
    2014-11-10
  • 사례 출판 날짜
    2015-01-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-12-21
  • 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
    Fluorometer, for clinical use - Product Code KHO
  • 원인
    Incorrect lumi firmware version installed (e.027 instead of v2.00).
  • 조치
    Tecan sent an Urgent Field Corrective Action letter dated October2014, to all affected consignees by via FedEx on/or about November 10, 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use te kinetic luminescence measurement workflow requiring movement of th eplate transport out during kinectice measurements until the firmware has been upgraded to current version 2.0. A Tecan service representative will contact you to arrange a time to install the firmware. Additionally, they may want to review prior measurement results obtained with this workflow. Customers with questions were advised to contacte their local Tecan Helpdesk. For questions regarding this recall call 919-361-5200, ext 19524.

Device

  • 모델명 / 제조번호(시리얼번호)
    Material number: 30050303, Lot numbers: 1010005108, 1012003953, 1108005760, 1306007560 and 1311008591.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.
  • 제품 설명
    Infinite 200PRO || The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.
  • Manufacturer

Manufacturer

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