Device Recall TDx/TDxFLx CReactive Protein Reagents

  • Modelo / Serial
    All lots with insert version 66-9771/R3. The corrected insert is version 34-2897/R4.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and internationally through Abbott subsidiaries in Mexico, Guatemala, Colombia, Chile, Argentina, Brazil, Puerto Rico, San Salvador, Canada, England, Japan, Singapore, Hong Kong, Taiwan, Thailand, Korea, Australia, New Zealand, Honduras, Costa Rica, Bahamas, Panama, Dominican Republic and China.
  • Descripción del producto
    TDx/TDxFLx C-Reactive Protein (CRP) Reagents, list 9550-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Abbott Laboratories HPD/ADD/GPRD, 100/200 Abbott Park Road, Abbott Park IL 60064
  • Source
    USFDA