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Devices
Device Recall Abbott Diabetes Care, MediSense Optium
Model / Serial
Lot codes: 45001A159, 45001A195, 45001A228, 45001A233, 45001A236, 45001A243, 45001A247, 45001A249, 45001A250, 45001A255, 45001A279, 45001A285, 45001A295, 45001A298, 45001A306, 45001A317, 45001A318, 45001A327, 45001A346, 45001A398, 45001A449, 45001A469, 45001A578, 45001A693, 45001A697, 45001A747, 45001A790, 45001A795, 45001A839, 45001A917; MediSense Optium Blood Glucose Electrodes: 45001A133, 45001A137, 45001A226, 45001A252, 45001A257, 45001A277, 45001A285, 45001A817, 45001A835, 45001A921, 45001C001.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Products were released for distribution in US and Puerto Rico.
Product Description
Abbott Diabetes Care, MediSense Optium Blood Glucose Test Strips; || MediSense Optium Blood Glucose Electrodes;
Manufacturer
Abbott Diabetes Care, Inc.
1 Event
Recall of Device Recall Abbott Diabetes Care, MediSense Optium
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Manufacturer
Abbott Diabetes Care, Inc.
Manufacturer Address
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda CA 94502-7000
Source
USFDA
Language
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