Device Recall BD BACTEC FX Top Unit instrument

  • 모델명 / 제조번호(시리얼번호)
    Catalog number 441385 and 441386
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to IN, AU, CN, AR, BE, PE, KR, BR, CO, SG, TH, BN, HK, JP, and CA.
  • 제품 설명
    BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. || The BD BACTEC FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • 제조사 모회사 (2017)
  • Source
    USFDA