Devices

Device Recall T2CandidaCartridges

  • Modèle / numéro de série
    Lot Numbers:  000048532541 000048730657 000049837721 000050205643 000050205642 000050205641 000050205644 000051259462 000051269868 000051807669 000051989614 000052596978
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to the states of UT, FL, NH, PA, GA, MI, AL, IN, NJ, CA, NY, LA, RI, TN, TX, WI, and CT.
  • Description du dispositif
    T2Candida¿Cartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartridge base). || A qualitative T2 Magnetic Resonance (T2MR¿) assay for the direct detection of Candida species in EDTA human whole blood specimens.
  • Manufacturer
    T2 Biosystems Inc
  • 1 Event

Fabricant

T2 Biosystems Inc
  • Adresse du fabricant
    T2 Biosystems Inc, 101 Hartwell Ave, Lexington MA 02421-3125
  • Société-mère du fabricant (2017)
    T2 Biosystems, Inc.
  • Source
    USFDA