Device Recall GBS Detect

  • Model / Serial
    Lot H16054 and H15056.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    U.S. Distribution to the following states: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, and TX.
  • Product Description
    Hardy Diagnostics GBS Detect || Cat no. A300. || Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Hardy Diagnostics, 1430 W McCoy Ln, Santa Maria CA 93455-1005
  • Manufacturer Parent Company (2017)
  • Source
    USFDA