Device Recall PrepStain Tecan USII

  • Model / Serial
    Catalog Numbers - 799-14000-00 (490100) and 799-14000-00R (490407)
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.
  • Product Description
    PrepStain Tecan US-II. || For use in the screening and detection of cervical cancer.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Manufacturer Parent Company (2017)
  • Source
    USFDA