Z-0413-2026 Class II Ongoing
FDA device recall Z-0413-2026 was initiated by Trividia Health, Inc. on October 7, 2025 and is designated Class II. 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 d… The recall status is ongoing. Affected quantity: 601 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 5, 2025
- Initiation Date
- October 7, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 601 units
Product Description
Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.
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 Pattern
US Nationwide distribution in the states of NY, VA, FL, OH, CA, KY, NC.
Code Information
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, T13909527, T13909528, T13909529, T13909530, T13909531, T13909532, T13909533, T13909534, T13909535, T13909536, T13909537, T13909538, T13909539, T13909540, T13909541, T13909542, T13909543, T13909544, T13909545, T13909546, T13909547, T13909548, T13909549, T13909550, T13909551, T13909552, T13909553, T13909554, T13909555, T13909556, T13909557, T13909558, T13909559, T13909560, T13909561, T13909562, T13909563, T13909564, T13909565, T13909566, T13909567, T13909568, T13909569, T13909570, T13909571, T13909572, T13909573, T13909574, T13909575, T13909576, T13909577, T13909578, T13909579, T13909580, T13909581, T13909582, T13909583, T13909584, T13909586, T13909587, T13909588, T13909589, T13909590, T13909591, T13909592, T13909593, T13909594, T13909595, T13909596, T13909597, T13909598, T13909599, T13909600, T13909981, T13909982, T13909983, T13909984, T13909985, T13909987, T13909988, T13909989, T13909990, T13911201, T13911203, T13911204, T13911205, T13911206, T13911207, T13911208, T13911209, T13911210, T13911211, T13911212, T13911213, T13911214, T13911215, T13911216, T13911217, T13911219, T13911220, T13911221, T13911222, T13911223, T13911224, T13911225, T13911226, T13911227, T13911228, T13911229, T13911230, T13911231, T13911232, T13911233, T13911236, T13911237, T13911238, T13911239, T13911240, T13911241, T13911242, T13911243, T13911244, T13911245, T13911246, T13911247, T13911248, T13911249, T13911250, T13911251, T13911252, T13911253, T13911254, T13911255, T13911256, T13911257, T13911258, T13911259, T13911260, T13911261, T13911262, T13911263, T13911264, T13911265, T13911266, T13911267, T13911268, T13911269, T13911270, T13911271, T13911272, T13911273, T13911274, T13911275, T13911276, T13911277, T13911278, T13911279, T13911280, T13911281, T13911282, T13911283, T13911284, T13911285, T13911286, T13911287, T13911288, T13911289, T13911290, T13911291, T13911292, T13911293, T13911294, T13911295, T13911296, T13911297, T13911298, T13911299, T13911300, T13911501, T13911502, T13911503, T13911504, T13911505, T13911506, T13911507, T13911508, T13911509, T13911510, T13911511, T13911512, T13911513, T13911514, T13911515, T13911516, T13911517, T13911518, T13911519, T13911520, T13911521, T13911522, T13911523, T13911524, T13911525, T13911526, T13911527, T13911528, T13911529, T13911530, T13911531, T13911532, T13911533, T13911534, T13911535, T13911536, T13911537, T13911538, T13911539, T13911540, T13911541, T13911542, T13911543, T13911544, T13911545, T13911546, T13911547, T13911548, T13911549, T13911550, T13911551, T13911552, T13911553, T13911554, T13911555, T13911556, T13911557, T13911558, T13911559, T13911560, T13911561, T13911562, T13911563, T13911564, T13911565, T13911566, T13911567, T13911568, T13911569, T13911570, T13911571, T13911572, T13911573, T13911574, T13911575, T13911576, T13911577, T13911578, T13911579, T13911580, T13911581, T13911582, T13911583, T13911584, T13911585, T13911586, T13911587, T13911588, T13911589, T13911590, T13911591, T13911592, T13911593, T13911594, T13911595, T13911596, T13911597, T13911598, T13911599, T13911600, T13912001, T13912002, T13912003, T13912004, T13912005, T13912006, T13912007, T13912008, T13912009, T13912010, T13912011, T13912012, T13912013, T13912014, T13912015, T13912016, T13912017, T13912018, T13912019, T13912020, T13912021, T13912022, T13912023, T13912024, T13912025, T13912026, T13912027, T13912028, T13912029, T13912030, T13912031, T13912032, T13912033, T13912034, T13912035, T13912036, T13912037, T13912038, T13912039, T13912040, T13912041, T13912042, T13912043, T13912044, T13912045, T13912046, T13912047, T13912048, T13912049, T13912050, T13912051, T13912052, T13912053, T13912054, T13912056, T13912057, T13912058, T13912059, T13912060, T13912061, T13912062, T13912063, T13912064, T13912065, T13912066, T13912067, T13912068, T13912069, T13912070, T13912071, T13912072, T13912073, T13912074, T13912075, T13912076, T13912077, T13912078, T13912079, T13912080, T13912081, T13912082, T13912083, T13912084, T13912085, T13912086, T13912087, T13912088, T13912089, T13912090, T13912091, T13912092, T13912093, T13912094, T13912095, T13912096, T13912097, T13912098, T13912099, T13912100, T13912201, T13912202, T13912203, T13912204, T13912205, T13912206, T13912207, T13912208, T13912209, T13912210, T13912211, T13912212, T13912213, T13912214, T13912215, T13912216, T13912217, T13912218, T13912219, T13912220, T13912221, T13912222, T13912223, T13912224, T13912225, T13912226, T13912227, T13912228, T13912229, T13912230, T13912231, T13912232, T13912233, T13912234, T13912235, T13912236, T13912237, T13912238, T13912239, T13912240, T13912241, T13912242, T13912244, T13912245, T13912246, T13912247, T13912248, T13912249, T13912250, T13912251, T13912252, T13912253, T13912254, T13912255, T13912256, T13912257, T13912258, T13912259, T13912260, T13912261, T13912262, T13912263, T13912264, T13912265, T13912266, T13912267, T13912268, T13912269, T13912270, T13912271, T13912272, T13912273, T13912274, T13912275, T13912276, T13912277, T13912278, T13912279, T13912280, T13912281, T13912282, T13912283, T13912284, T13912285, T13912286, T13912287, T13912288, T13912289, T13912290, T13912291, T13912292, T13912293, T13912294, T13912295, T13912296, T13912297, T13912298, T13912299, T13912300. Expiration Date: 02/21/2030.