Device Recall SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL

  • Modèle / numéro de série
    Lot Numbers: 38050 and 38060.
  • Classification du dispositif
  • Classe de dispositif
    2
  • 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 Synovialscopics Synovial Fluid Control. || Synovialscopics is a plastic bottle Synovial fluid cell count control. It is a control for monitoring total cell counts in patient Synovial fluid samples performed manually using a hemocytometer. It is also an aid for identifying the crystals which may indicate a pathological condition present in the Synovial fluid. This control is used as a third party control to confirm proper functioning of the analysis by microscopic evaluation.
  • 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