Devices

Device Recall Duane Reade TRUEtrack monitor kit

  • Modèle / numéro de série
    Finished Good (FG) Kit Lot# KL01009-3TI, TRUEtrack Test Strip Lot# RL3435; FG Kit Lot# KL01009-12TI, TRUEtrack Test Strip Lot# RL3435; FG Kit Lot# KL01233-4TI, TRUEtrack Test Strip Lot# RL3476; FG Kit Lot# KM0548TI, TRUEtrack Test Strip Lot# RM3547; FG Kit Lot# KM0645TI, TRUEtrack Test Strip Lot# RM3562; FG Lot# KM0692TI, TRUEtrack Test Strip Lot# RM3562.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution only in NY.
  • Description du dispositif
    Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 || The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
  • Manufacturer
    Nipro Diagnostics, Inc.
  • 1 Event

Fabricant

Nipro Diagnostics, Inc.
  • Adresse du fabricant
    Nipro Diagnostics, Inc., 2400 NW 55th Ct, Ft Lauderdale FL 33309-2672
  • Société-mère du fabricant (2017)
    Nipro Corporation
  • Source
    USFDA