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

  • 모델명 / 제조번호(시리얼번호)
    Not applicable
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    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

제조사

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