Devices

Device Recall TDx/TDxFLx REA Ethanol

Model / Serial
All lots with insert version 69-5787/R4. The corrected insert is version 34-2778/R5.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
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
TDx/TDxFLx REA Ethanol, list 9545-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
Manufacturer
Abbott Laboratories HPD/ADD/GPRD
1 Event
- Recall of Device Recall TDx/TDxFLx REA Ethanol

Manufacturer

Abbott Laboratories HPD/ADD/GPRD

Manufacturer Address
Abbott Laboratories HPD/ADD/GPRD, 100/200 Abbott Park Road, Abbott Park IL 60064
Source
USFDA

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