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

  • Model / Serial
    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
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Dako North America Inc., 6392 Via Real, Carpinteria CA 93013-2921
  • Manufacturer Parent Company (2017)
  • Source
    USFDA