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Manufacturers
Abbott Diabetes Care, Inc.
제조사 주소
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda CA 94502-7000
Source
USFDA
31 Events
Device Recall Abbott Diabetes Care, ReliOn Ultima 의 리콜
Device Recall Abbott Diabetes Care, Precision Xtra 의 리콜
Device Recall Abbott Diabetes Care, Precision Point of Care 의 리콜
Device Recall Abbott Diabetes Care, Optium 의 리콜
Device Recall Abbott Diabetes Care, MediSense Optium 의 리콜
Device Recall Abbott Diabetes Care Optium EZ 의 리콜
Device Recall Abbott Diabetes Care Precision Xceed Pro 의 리콜
Device Recall FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM 의 리콜
Freestyle Navigator Continuous Glucose Monitor System 의 리콜
Freestyle Navigator Continuous Glucose Monitor System 의 리콜
Freestyle Navigator Continuous Glucose Monitor System 의 리콜
Freestyle Navigator Continuous Glucose Monitor System 의 리콜
Freestyle Navigator Continuous Glucose Monitor System 의 리콜
Freestyle Navigator Continuous Glucose Monitor System 의 리콜
Freestyle Navigator Continuous Glucose Monitor System 의 리콜
Freestyle Navigator Continuous Glucose Monitor System 의 리콜
Freestyle Navigator Continuous Glucose Monitor System 의 리콜
Freestyle Navigator Continuous Glucose Monitor System 의 리콜
Freestyle Navigator Continuous Glucose Monitor System 의 리콜
Freestyle Navigator Continuous Glucose Monitor System 의 리콜
Freestyle Navigator Continuous Glucose Monitor System 의 리콜
Freestyle Navigator Continuous Glucose Monitor System 의 리콜
Freestyle Navigator Continuous Glucose Monitor System 의 리콜
Freestyle Navigator Continuous Glucose Monitor System 의 리콜
Freestyle Navigator Continuous Glucose Monitor System 의 리콜
Freestyle Navigator Continuous Glucose Monitor System 의 리콜
Freestyle Navigator Continuous Glucose Monitor System 의 리콜
Freestyle Navigator Continuous Glucose Monitor System 의 리콜
Device Recall FreeStyle Connect 의 리콜
Device Recall FreeStyle Connect 의 리콜
Device Recall FreeStyle CoPilot 의 리콜
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데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 31 건
Device Recall Abbott Diabetes Care, ReliOn Ultima
모델명 / 제조번호(시리얼번호)
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.
의료기기 분류등급
Clinical Chemistry and Clinical Toxicology Devices
의료기기 등급
2
이식된 장치?
No
유통
Products were released for distribution in US and Puerto Rico.
제품 설명
Abbott Diabetes Care, ReliOn Ultima Blood Glucose Test ;
Device Recall Abbott Diabetes Care, Precision Xtra
모델명 / 제조번호(시리얼번호)
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.
의료기기 분류등급
Clinical Chemistry and Clinical Toxicology Devices
의료기기 등급
2
이식된 장치?
No
유통
Products were released for distribution in US and Puerto Rico.
제품 설명
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
모델명 / 제조번호(시리얼번호)
Lot codes: 45515, 45517, 45701, 45791, 45963, 45964, 46367
의료기기 분류등급
Clinical Chemistry and Clinical Toxicology Devices
의료기기 등급
2
이식된 장치?
No
유통
Products were released for distribution in US and Puerto Rico.
제품 설명
Abbott Diabetes Care, Precision Point of Care Blood Glucose Test Strips;
Device Recall Abbott Diabetes Care, Optium
모델명 / 제조번호(시리얼번호)
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
의료기기 분류등급
Clinical Chemistry and Clinical Toxicology Devices
의료기기 등급
2
이식된 장치?
No
유통
Products were released for distribution in US and Puerto Rico.
제품 설명
Abbott Diabetes Care, Optium Blood Glucose Test Strips;
Device Recall Abbott Diabetes Care, MediSense Optium
모델명 / 제조번호(시리얼번호)
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.
의료기기 분류등급
Clinical Chemistry and Clinical Toxicology Devices
의료기기 등급
2
이식된 장치?
No
유통
Products were released for distribution in US and Puerto Rico.
제품 설명
Abbott Diabetes Care, MediSense Optium Blood Glucose Test Strips; || MediSense Optium Blood Glucose Electrodes;
하나 더 26 건 더
유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건
데이터에 대해 더 자세히 알아보기
여기
Abbott Diabetes Care, Inc.
제조사 주소
Abbott Diabetes Care, Inc., 1360 S Loop Rd, Alameda CA 94502-7000
Source
USFDA
Language
English
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