Device Recall FilmArray Blood Culture Identification Panel

  • 모델명 / 제조번호(시리얼번호)
    All lot numbers are involved. UDI: 00815381020086 (RFIT-ASY-0126), 00815381020093 (RFIT-ASY-0127).  The expiration dates of the BD BACTEC Blood Culture Bottles are 9/30/2018 and beyond.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Botswana, Brazil, Chile, Colombia, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, France, French Polynesia, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Malaysia, Mexico, Myanmar, The Netherlands, New Caledonia, Nicaragua, Panama, Peru, Republic of the Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay.
  • 제품 설명
    FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    BioFire Diagnostics, LLC, 515 S Colorow Dr, Salt Lake City UT 84108-1248
  • 제조사 모회사 (2017)
  • Source
    USFDA