Device Recall SPINALSCOPICS

  • Modèle / numéro de série
    Lot Numbers: 46130, 46131, 46132, 46140, 46141, 46142, 46150, 46151, 46152, 46160, 46161, 46162, 46170, 46171 and 46172.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including states of AK, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, NC, ND, NH, NM, NY, OR, PA, SC, SD, TN, TX, VA, WA and WY.
  • Description du dispositif
    Quantimetrix SpinalScopics Spinal Fluid Cell Count Control. || Spinalscopics is a plastic bottle liquid spinal fluid cell count control. This product is intended for monitoring cell counts in patient cerebrospinal fluid samples performed manually using a hemocytometer.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Quantimetrix Corporation, 2005 Manhattan Beach Blvd, Redondo Beach CA 90278-1205
  • Société-mère du fabricant (2017)
  • Source
    USFDA