Device Recall ABX PENTRA Urine Control L/H

  • Modèle / numéro de série
    Model/Part #(s): A11A01674. Lot/Serial #(s): 1207001, 1303601, and 1300701. Shelf Life: Lot#s 1207001 & 1300701 Expire on: 06/30/2014. Lot# 1303601 Expires on: 09/30/2014.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Canada.
  • Description du dispositif
    ABX PENTRA Urine Control L/H. || The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control || consisting of liquid solutions prepared from human urine with chemical additives and || materials of biological origin added as required to obtain given component levels. The || assigned values of the control components are given in the labeling, ensuring control of || the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers. || Each control level is provided in one vial of 10 ml. || The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Horiba Instruments, Inc dba Horiba Medical, 34 Bunsen, Irvine CA 92618-4210
  • Société-mère du fabricant (2017)
  • Source
    USFDA