Device Recall ADx

  • Model / Serial
    List no. 9681-55
  • Product Classification
  • Distribution
    Distribution was nationwide, VA/DOD accounts. The foreign distribution was as follows: Mexico, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Canada, England, Japan, Singapore, Hong Kong, Taiwan, Thailand, Costa Rica, New Zealand and Panama
  • Product Description
    ADx Tricyclic Antidepressants Reagent. || Distributed under the following label: || ADx, Abbott Laboratories USA, North Chicago, IL 60064
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Abbott Health Products, Inc., Hwy 2 Km 58.0, Barceloneta PR 00617
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Product List number: 9681-55.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was nationwide.
  • Product Description
    ADx Tricyclic Antidepressants Reagent. Distributed under the following label: ADx Tricyclic Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064
  • Manufacturer
  • Model / Serial
    All lots with insert version 69-5997/R4. The corrected insert is version 69-6506/R5.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    ADx Methadone, list 9676-55; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
  • Manufacturer