Device Recall cobas 6000 Series system/Modular e601: Immunoassay Analyzer

  • Modèle / numéro de série
    Not applicable
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    cobas 6000 Series system || c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay Analyzer || Product Usage: || The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. Automatic retrieval for add-on testing is possible at any time. Expired samples are disposed of automatically when their storage time has elapsed. The instrument is intended as accessory for diagnostic use.
  • 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