Events

Device Recall VersaTREK Windows Software, Version 5.4.3 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Trek Diagnostic Systems 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
    62757
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2323-2012
  • 사례 시작날짜
    2012-07-23
  • 사례 출판 날짜
    2012-09-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-06-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111647
  • 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
    System, blood culturing - Product Code MDB
  • 원인
    Review of instrument software databases and investigation of two customer reports determined that on rare occasions (less than 0.3%), following the removal of a positive signaling bottle from the versatrek instrument, the positive test result inadvertently reverted to a negative result in the instrument database.
  • 조치
    ThermoFisher Scientific sent an Important Medical Device Product Correction Notice dated July 19, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact the Technical Service Department at 800-642-7029 to schedule their upgrade and to complete and return the Correction Notice Customer Acknowledgement by fax or in the enclosed return envelope. Customers were also asked to return the checklist. For questions customers were instructed to call 800-642-7029. For questions regarding this recall call 913-985-4185.

Device

Device Recall VersaTREK Windows Software, Version 5.4.3
  • 모델명 / 제조번호(시리얼번호)
    Software: Cat. 6133-30-3, Version 5.4.3.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO , CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV, and WY. Internationally to the countries of Bahamas, Bangladesh, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, India, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Malaysia, Mexico, Pakistan, Peru, Philippines, Portugal, Puerto Rico, Russian Federation, South Africa, Spain, Thailand, Turkey, and United Kingdom
  • 제품 설명
    VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer || The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids.
  • Manufacturer
    Trek Diagnostic Systems

Manufacturer

Trek Diagnostic Systems
  • 제조사 주소
    Trek Diagnostic Systems, 982 Keynote Cir Ste 6, Cleveland OH 44131-1873
  • Source
    USFDA