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

  • Model / Serial
    Not applicable
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Manufacturer Parent Company (2017)
  • Source
    USFDA