Device Recall TDx/TDxFLx and TDxFLx Carbamazepine Reagents

  • Modèle / numéro de série
    Reagent List 9515-60, lot 03492Q100 and Reagent List 9515-85, lot 04530Q100 that contain insert item number 69-5121/R4
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and internationally through Abbott subsidiaries in Mexico, Guatemala, Venezuela, Colombia, Peru, Chile, Uruguay, Argentina, Brazil, Puerto Rico, San Salvador, Canada, Germany, England, Japan, Singapore, Hong Kong, India, Taiwan, Thailand, Malaysia, Pakistan, Korea, Australia, New Zealand, Honduras, Costa Rica, Aruba, Bahamas, Panama, St. Croix, Jamaica and Paraguay.
  • Description du dispositif
    Package Insert for TDx/TDxFLx and TDxFLx Carbamazepine Reagents, REF 9515, item number 69-5121/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Abbott Laboratories HPD/ADD/GPRD, 100/200 Abbott Park Road, Abbott Park IL 60064
  • Source
    USFDA