About the database
How to use the database
Download the data
FAQ
Credits
Manufacturers
Abbott Diabetes Care, Inc.
Manufacturer Address
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda CA 94502-7000
Source
USFDA
31 Events
Recall of Device Recall Abbott Diabetes Care, ReliOn Ultima
Recall of Device Recall Abbott Diabetes Care, Precision Xtra
Recall of Device Recall Abbott Diabetes Care, Precision Point of Care
Recall of Device Recall Abbott Diabetes Care, Optium
Recall of Device Recall Abbott Diabetes Care, MediSense Optium
Recall of Device Recall Abbott Diabetes Care Optium EZ
Recall of Device Recall Abbott Diabetes Care Precision Xceed Pro
Recall of Device Recall FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
Recall of Freestyle Navigator Continuous Glucose Monitor System
Recall of Freestyle Navigator Continuous Glucose Monitor System
Recall of Freestyle Navigator Continuous Glucose Monitor System
Recall of Freestyle Navigator Continuous Glucose Monitor System
Recall of Freestyle Navigator Continuous Glucose Monitor System
Recall of Freestyle Navigator Continuous Glucose Monitor System
Recall of Freestyle Navigator Continuous Glucose Monitor System
Recall of Freestyle Navigator Continuous Glucose Monitor System
Recall of Freestyle Navigator Continuous Glucose Monitor System
Recall of Freestyle Navigator Continuous Glucose Monitor System
Recall of Freestyle Navigator Continuous Glucose Monitor System
Recall of Freestyle Navigator Continuous Glucose Monitor System
Recall of Freestyle Navigator Continuous Glucose Monitor System
Recall of Freestyle Navigator Continuous Glucose Monitor System
Recall of Freestyle Navigator Continuous Glucose Monitor System
Recall of Freestyle Navigator Continuous Glucose Monitor System
Recall of Freestyle Navigator Continuous Glucose Monitor System
Recall of Freestyle Navigator Continuous Glucose Monitor System
Recall of Freestyle Navigator Continuous Glucose Monitor System
Recall of Freestyle Navigator Continuous Glucose Monitor System
Recall of Device Recall FreeStyle Connect
Recall of Device Recall FreeStyle Connect
Recall of Device Recall FreeStyle CoPilot
{{ $t('card.reduce') }}
{{ $tc('card.more', left) }}
31 devices in the database
Device Recall Abbott Diabetes Care, ReliOn Ultima
Model / Serial
Lot codes: 45358, 45369, 45377, 45379, 45466, 45504, 45511, 45608, 45613, 45641, 45642, 45644, 45672, 45674, 45675, 45676, 45677, 45721, 45734, 45736, 45739, 45742, 45743, 45789, 45790, 45800, 45801, 45840, 45841, 45849, 45850, 46008, 46009, 46061, 46067, 46069, 46072, 46103, 46105, 46148, 46201, 46202, 46214, 46215, 46232, 46313, 46332, 46336, 46338, 46341, 46368.
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, ReliOn Ultima Blood Glucose Test ;
Device Recall Abbott Diabetes Care, Precision Xtra
Model / Serial
Lot codes: 45001A330, 45001A467, 45001A481, 45001A482, 45001A483, 45001A487, 45001A488, 45001A496, 45001A497, 45001A499, 45001A500, 45001A503, 45001A505, 45001A506, 45001A510, 45001A511, 45001A513, 45001A519, 45001A520, 45001A521, 45001A530, 45001A532, 45001A534, 45001A536, 45001A537, 45001A545, 45001A556, 45001A565, 45001A566, 45001A568, 45001A573, 45001A577, 45001A584, 45001A594, 45001A595, 45001A597, 45001A605, 45001A607, 45001A608, 45001A609, 45001A613, 45001A614, 45001A626, 45001A634, 45001A637, 45001A641, 45001A644, 45001A645, 45001A656, 45001A660, 45001A664, 45001A669, 45001A670, 45001A671, 45001A677, 45001A678, 45001A682, 45001A685, 45001A694, 45001A700, 45001A705, 45001A706, 45001A707, 45001A709, 45001A712, 45001A730, 45001A732, 45001A739, 45001A742, 45001A744, 45001A751, 45001A753, 45001A757, 45001A762, 45001A777, 45001A778, 45001A786, 45001A788, 45001A790, 45001A798, 45001A806, 45001A814, 45001A815, 45001A816, 45001A820, 45001A840, 45001A842, 45001A847, 45001A852, 45001A856, 45001A860, 45001A861, 45001A872, 45001A876, 45001A882, 45001A910, 45001A912, 45001A914, 45001A918, 45001A920, 45001A921, 45001A940, 45001A947, 45001A948, 45001A949, 45001A971, 45001A976, 45001A979, 45001A982, 45001A983, 45001C008, 45001C011, 45001C012 45384, 45388, 45396, 45407, 45418, 45455, 45456, 45463, 45464, 45512, 45514, 45516, 45521, 45611, 45612, 45614, 45619, 45627, 45632, 45639, 45645, 45646, 45653, 45670, 45679, 45680, 45682, 45707, 45708, 45724, 45729, 45731, 45732, 45733, 45735, 45737, 45738, 45755, 45777, 45782, 45783, 45784 Precision Xtra Blood Glucose & Ketone Monitoring System: 01P107D, 01P128D, 01P139D, 02P140D, 01P153D, 02P201D, 02P223D, 02P229D, 03P107D, 03P155D, 03P158D, 03P194D, 03P209D, 03P222D, 03P223D, 03P242D, 04P154D, 04P194D, 04P201D, 04P315D, 05P106D, 05P107D, 05P127D, 05P130D, 05P138D, 05P139D, 05P140D, 05P152D, 05P201D, 06P180D, 06P322D, 07P141D, 08P106D, 08P138D, 08P279D, 09P106D, 09P140D; Precision G3b Smartblue Blood Glucose Test Strips: 45001A710.
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, Precision Xtra Blood Glucose Test Strips; || Precision Xtra Blood Glucose & Ketone Monitoring System; || Precision G3b Smartblue Blood Glucose Test Strips;
Device Recall Abbott Diabetes Care, Precision Point of Care
Model / Serial
Lot codes: 45515, 45517, 45701, 45791, 45963, 45964, 46367
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, Precision Point of Care Blood Glucose Test Strips;
Device Recall Abbott Diabetes Care, Optium
Model / Serial
Lot codes: 45001A484, 45001A486, 45001A512, 45001A514, 45001A517, 45001A519, 45001A527, 45001A541, 45001A544, 45001A552, 45001A558, 45001A564, 45001A572, 45001A598, 45001A665, 45001A677, 45001A709, 45001A713, 45001A732, 45001A771, 45001A819, 45001A852 45455, 45516, 45708, 45709, 45737, 45738, 45777, 45778, 45783
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, Optium Blood Glucose Test Strips;
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;
26 more
One manufacturer with a similar name
Learn more about the data
here
Abbott Diabetes Care, Inc.
Manufacturer Address
Abbott Diabetes Care, Inc., 1360 S Loop Rd, Alameda CA 94502-7000
Source
USFDA
Language
English
Français
Español
한국어