Device Recall BacT/ALERT SA Blood Culture Bottle

  • Model / Serial
    Catalog Number: 259789, Lots/Batch: 1031866
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.USA including the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WI, and WV, and the countries of China, Curacao and Japan.
  • Product Description
    BacT/ALERT SA Blood Culture Bottle. || The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    bioMerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • Manufacturer Parent Company (2017)
  • Source
    USFDA