Device Recall ABX PENTRA Lactic Acid CPref. A11A01721

  • Model / Serial
    All Lots
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.
  • Product Description
    ABX PENTRA Lactic Acid CP ref. A11A01721 || reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in plasma by colorimetry. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Horiba Instruments Inc, 9755 Research Dr, Irvine CA 92618-4626
  • Manufacturer Parent Company (2017)
  • Source
    USFDA