Device Recall TDx/TDxFLx REA Ethanol

All lots with insert version 69-5787/R4. The corrected insert is version 34-2778/R5.

Clinical Chemistry and Clinical Toxicology Devices

2

No

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.

TDx/TDxFLx REA Ethanol, list 9545-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064