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

  • 모델명 / 제조번호(시리얼번호)
    Not applicable
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    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

제조사

  • 제조사 주소
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • 제조사 모회사 (2017)
  • Source
    USFDA