Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.
Reason for recall: Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management. Distribution: US Nationwide distribution in the states of NY, VA, FL, OH, CA, KY, NC. Quantity: 601 units Lot/code info: Model/Catalog Number: RE4011-01. UDI-DI (Meter Kit): 00087701426254. UDI-DI (Meter): 00021292007690. Serial Numbers: T13908301, T13908302, T13908303, T13908304, T13908305, T13908306, T13908307, T13908308, T13908309, T13908310, T13908311, T13908312, T13908313, T13908314, T13908315, T13908316, T13908317, T13908318, T13908319, T13908320, T13908321, T13908322, T13908323, T13908324, T13908325, T13908326, T13908327, T13908328, T13908329, T13908330, T13908331, T13908332, T13908333, T13908335, T13908336, T13908337, T13908338, T13908339, T13908340, T13908341, T13908342, T13908343, T13908344, T13908345, T13908346, T13908347, T13908348, T13908349, T13908350, T13908351, T13908352, T13908353, T13908354, T13908355, T13908356, T13908357, T13908358, T13908359, T13908360, T13908361, T13908362, T13908363, T13908364, T13908365, T13908366, T13908367, T13908368, T13908369, T13908370, T13908371, T13908372, T13908373, T13908374, T13908375, T13908376, T13908377, T13908378, T13908379, T13908380, T13908381, T13908382, T13908383, T13908384, T13908385, T13908386, T13908387, T13908388, T13908389, T13908390, T13908391, T13908392, T13908393, T13908394, T13908395, T13908396, T13908397, T13908398, T13908399, T13908400, T13909501, T13909502, T13909503, T13909504, T13909505, T13909506, T13909507, T13909508, T13909509, T13909510, T13909511, T13909512, T13909513, T13909514, T13909515, T13909516, T13909517, T13909518, T13909519, T13909520, T13909521, T13909522, T13909523, T13909524, T13909525, T13909526, T1390952
00087701426254, 00021292007690
Official record: FDA (Device enforcement) ↗
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