Device Recall Roche cobas 6800/8800 system, Hepatitis Viral B DNA Detection

  • Modèle / numéro de série
    Not applicable
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    cobas 6800/8800 system || Hepatitis Viral B DNA Detection || Product Usage: || The cobas p512 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged sample tubes. It includes modules for registration and decapping of sample tubes, liquid level detection (optional) and sample quality detection (optional), as well as recapping of sample tubes (optional).
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Société-mère du fabricant (2017)
  • Source
    USFDA