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Crédits
Manufacturers
Abbott Diabetes Care, Inc.
Adresse du fabricant
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda CA 94502-7000
Source
USFDA
31 Events
Rappel de Device Recall Abbott Diabetes Care, ReliOn Ultima
Rappel de Device Recall Abbott Diabetes Care, Precision Xtra
Rappel de Device Recall Abbott Diabetes Care, Precision Point of Care
Rappel de Device Recall Abbott Diabetes Care, Optium
Rappel de Device Recall Abbott Diabetes Care, MediSense Optium
Rappel de Device Recall Abbott Diabetes Care Optium EZ
Rappel de Device Recall Abbott Diabetes Care Precision Xceed Pro
Rappel de Device Recall FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
Rappel de Freestyle Navigator Continuous Glucose Monitor System
Rappel de Freestyle Navigator Continuous Glucose Monitor System
Rappel de Freestyle Navigator Continuous Glucose Monitor System
Rappel de Freestyle Navigator Continuous Glucose Monitor System
Rappel de Freestyle Navigator Continuous Glucose Monitor System
Rappel de Freestyle Navigator Continuous Glucose Monitor System
Rappel de Freestyle Navigator Continuous Glucose Monitor System
Rappel de Freestyle Navigator Continuous Glucose Monitor System
Rappel de Freestyle Navigator Continuous Glucose Monitor System
Rappel de Freestyle Navigator Continuous Glucose Monitor System
Rappel de Freestyle Navigator Continuous Glucose Monitor System
Rappel de Freestyle Navigator Continuous Glucose Monitor System
Rappel de Freestyle Navigator Continuous Glucose Monitor System
Rappel de Freestyle Navigator Continuous Glucose Monitor System
Rappel de Freestyle Navigator Continuous Glucose Monitor System
Rappel de Freestyle Navigator Continuous Glucose Monitor System
Rappel de Freestyle Navigator Continuous Glucose Monitor System
Rappel de Freestyle Navigator Continuous Glucose Monitor System
Rappel de Freestyle Navigator Continuous Glucose Monitor System
Rappel de Freestyle Navigator Continuous Glucose Monitor System
Rappel de Device Recall FreeStyle Connect
Rappel de Device Recall FreeStyle Connect
Rappel de Device Recall FreeStyle CoPilot
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31 dispositifs dans la base de données
Device Recall Abbott Diabetes Care, ReliOn Ultima
Modèle / numéro de série
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.
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Products were released for distribution in US and Puerto Rico.
Description du dispositif
Abbott Diabetes Care, ReliOn Ultima Blood Glucose Test ;
Device Recall Abbott Diabetes Care, Precision Xtra
Modèle / numéro de série
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.
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Products were released for distribution in US and Puerto Rico.
Description du dispositif
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
Modèle / numéro de série
Lot codes: 45515, 45517, 45701, 45791, 45963, 45964, 46367
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Products were released for distribution in US and Puerto Rico.
Description du dispositif
Abbott Diabetes Care, Precision Point of Care Blood Glucose Test Strips;
Device Recall Abbott Diabetes Care, Optium
Modèle / numéro de série
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
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Products were released for distribution in US and Puerto Rico.
Description du dispositif
Abbott Diabetes Care, Optium Blood Glucose Test Strips;
Device Recall Abbott Diabetes Care, MediSense Optium
Modèle / numéro de série
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.
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Products were released for distribution in US and Puerto Rico.
Description du dispositif
Abbott Diabetes Care, MediSense Optium Blood Glucose Test Strips; || MediSense Optium Blood Glucose Electrodes;
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Abbott Diabetes Care, Inc.
Adresse du fabricant
Abbott Diabetes Care, Inc., 1360 S Loop Rd, Alameda CA 94502-7000
Source
USFDA
Language
English
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