Devices

Device Recall Boule ConDiff TriLevel

  • Modelo / Serial
    Product Part Number: 501-605 Lot# 1311-682 Exp. 3/26/2014 501-607 Lot# 1311-683, 1311-684 Exp. 3/26/2014 501-608 Lot# 1311-683 Exp. 3/26/2014
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA Nationwide and the countries of IVORY COAST, MEXICO, and Philippines.
  • Descripción del producto
    Boule Con-Diff Tri-Level || Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
  • Manufacturer
    Clinical Diagnostic Solutions
  • 1 Event

Fabricante

Clinical Diagnostic Solutions
  • Dirección del fabricante
    Clinical Diagnostic Solutions, 1800 Nw 65th Ave Ste 2, Plantation FL 33313-4544
  • Empresa matriz del fabricante (2017)
    Boule Diagnostics AB
  • Source
    USFDA