Device Recall VersaTREK Automated Microbial Detection System

  • Modèle / numéro de série
    Serial numbers: 0169050501141020, 0169059801141031, 0169064701141210, 0169066801150105, 2200X1113, 2215X1113, 2236X1213, 2244X1213, 2272X0214, 2273X0214, 2274X0214, 2275X0214, 2298X0714, 2299X0714, 2300X0714, 2301X0714, 2303X0714, 2304X0714, 2326X0814, 2327X0814, and 2328X0814;
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (nationwide) to states of AZ, CO, FL, GA, IA, ID, LA, MI, MO, PR, TN, TX, VA, and WA and the countries of Canada, People's Republic of China, Egypt, Finland, France, Indonesia, Israel, Jordan, Kenya, Republic of Korea, Latvia, Romania, Russia, Spain, Thailand, United Kingdom, Uruguay, and Vietnam.
  • Description du dispositif
    VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. || The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Remel Inc, 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Société-mère du fabricant (2017)
  • Source
    USFDA