Device Recall QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL

  • Model / Serial
    Lot Number: 48170, 48171, 48172, 48180, 48181 and 48182.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    Quantimetrix QuanTscopics Urine Microscopics Control. || QuanTscopics is a plastic bottle liquid urine microscopic quality control. It is a bi-level control with stabilized human blood cells provide a means to validate the processing and is centrifugation of urine prior to microscopic analysis in compliance with CLIA regulations.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Quantimetrix Corporation, 2005 Manhattan Beach Blvd, Redondo Beach CA 90278-1205
  • Manufacturer Parent Company (2017)
  • Source
    USFDA