FDA Enforcement Class II Ongoing

Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.

Recall: Z-0413-2026 · Reported November 5, 2025

Enforcement

Recall Number: Z-0413-2026
Event ID: 97747
Classification: Class II
Status: Ongoing
Product Type: Devices
Firm: Trividia Health, Inc.
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: E-Mail
Report Date: November 5, 2025
Initiation Date: October 7, 2025
Classification Date: October 30, 2025
Address: 2400 Nw 55th Ct, N/A, Ft Lauderdale, FL, 33309-2672, United States

Description

Reason

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.

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, 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.

Distribution

US Nationwide distribution in the states of NY, VA, FL, OH, CA, KY, NC.

Quantity

601 units