Devices

Device Recall TDx/TDxFLx CReactive Protein Reagents

Model / Serial
All lots with insert version 66-9771/R3. The corrected insert is version 34-2897/R4.
Product Classification
Immunology and Microbiology 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 C-Reactive Protein (CRP) Reagents, list 9550-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
Manufacturer
Abbott Laboratories HPD/ADD/GPRD
1 Event
- Recall of Device Recall TDx/TDxFLx CReactive Protein 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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