Device Recall Autostainer Link 48, Autostainer Plus, Autostainer, and Autostainer Link Instrument

  • 모델명 / 제조번호(시리얼번호)
    992640 Rev. 02, 992085 Rev.no H, 992625 Rev.no F, 992326 Rev.no C  Affected dates: 12/2013-08/2014  Each device is labeled with a unique serial number.  Catalog/Model Number: - AS480 - S3800 - S3400 - AS100
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) and countries of: AT, AU, BE, CA, CH, DE, DK, ES, FR, GB, IE, IT, JP, NL, NO, PL, and SE.
  • 제품 설명
    Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Dako North America Inc., 6392 Via Real, Carpinteria CA 93013-2921
  • 제조사 모회사 (2017)
  • Source
    USFDA