Events

Device Recall VITEK 2 XL computer system 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Biomerieux 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
    64394
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0990-2013
  • 사례 시작날짜
    2013-02-18
  • 사례 출판 날짜
    2013-03-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-08-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116026
  • 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
    Susceptibility test cards, antimicrobial - Product Code LTW
  • 원인
    There is a potential to link an isolate result to the wrong patient and then upload the results to the lis.
  • 조치
    bioMerieux sent an "URGENT PRODUCT CORRECTION NOTICE" dated February 20, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Emails were issued by the recalling firm on 2/18/2013 and 2/19/2013 to their subsidiaries and to distributors. Letters began issuing to customers via e-mail on 2/20/2013. Contact bioMerieux Clinical Customer Service at (800) 682-2666 for questions regarding this notice.

Device

Device Recall VITEK 2 XL computer system
  • 모델명 / 제조번호(시리얼번호)
    Manufactured from September, 2004, to present.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Algeria, Angola, Argentina, Australia, Austria, Azerbaidjian, Bahrain, Belarus, Belgium, Benin, Bolivia, Bosnia, Brazil, Bulgaria, Burkina Faso, Camaroun, Canada, Chad, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Democratic Republic of Congo, Demark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gabon, Georgia, Germany, Greece, Guatemala, Guinea, Herzegovina, Honduras, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Myanmar, Netherlands, Netherlands, Nicaragua, Niger Niamey, Nigeria, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Yemen.
  • 제품 설명
    VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models: || (1) rp5700, Cat. #W0452; || (2) rp5700 (refurbished), Cat. #W0452R; || (3) rp5800 XPE, Cat. 413642; || (4) rp5800 WES7, Cat. #413862; || (5) dc7100 8-port, Cat. #W0441; || (6) dc7100 8-port (refurbished), Cat. #W0441R; || (7) dc7700 8-port, Cat. #W0447; || (8) dc7700 8-port (refurbished), Cat. #W0447R; || (9) dc7800, Cat. #W0449; and || (10) dc7800 (refurbished), Cat. #W0449R. || VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
  • Manufacturer
    Biomerieux Inc

Manufacturer

Biomerieux Inc
  • 제조사 주소
    Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
  • 제조사 모회사 (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA