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Devices
Device Recall Xtra Classic Glucose Monitoring System
Model / Serial
All lot numbers are included in this recall.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Approximately 10,005,206 meters have been distributed worldwide since 1999, with 5,885,332 meters distributed in the US, and 4,517,211 in use.
Product Description
Xtra Classic Glucose Monitoring System; || Recalling Firm/Manufacturer: || Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Manufacturer
Abbott Laboratories Medisense Products
1 Event
Recall of Device Recall Xtra Classic Glucose Monitoring System
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Manufacturer
Abbott Laboratories Medisense Products
Manufacturer Address
Abbott Laboratories Medisense Products, 1360 S Loop Rd, Alameda CA 94502-7000
Source
USFDA
Language
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