Device Recall TDx/TDxFLx and TDxFLx Vancomycin Reagents

Reagent List 9523-60, lots 05105Q100, 03122Q100, 01649Q101, 01649Q100, 01179Q102, 01179Q101, 01179Q100;and Reagent List 9523-85, lots 05576Q100, 01742Q100, 96817Q100, 92749Q100 that contain insert item number 69-5726/R4

Clinical Chemistry and Clinical Toxicology Devices

2

No

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.

Package Insert for TDx/TDxFLx and TDxFLx Vancomycin Reagents, REF 9523, item number 69-5726/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064