Devices

Device Recall TDx/TDxFLx and TDxFLx Vancomycin Reagents

Model / Serial
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
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
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.
Product Description
Package Insert for TDx/TDxFLx and TDxFLx Vancomycin Reagents, REF 9523, item number 69-5726/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
Manufacturer
Abbott Laboratories HPD/ADD/GPRD
1 Event
- Recall of Device Recall TDx/TDxFLx and TDxFLx Vancomycin Reagents

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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