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TRUE METRIX recallZ-0413-2026 · Trividia Health, Inc. · initiated Oct 7, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Trividia Health, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

Trividia Health notified consignees on about 10/07/2025 via email, letter and press release. Distributors were instructed to examine inventory for affected meters by reviewing the lot number printed on the outer case/shipper label or on the side of the Product's box. Affected units were directed to be returned per normal return procedures. Additionally, they were instructed to notify customers of the recall and request that they return affected units to the distributor. Pharmacists/DME Providers were instructed to examine inventory for affected meters reviewing the lot number in the same manner as distributors. Affected units in inventory or units received from patients, were requested to be returned per normal return procedures or call Trividia Health Customer Service Department. Pharmacists/DME Providers were instructed to advise patients with affected units to return them directly to their pharmacy and follow normal return procedures or contact Trividia Health Customer Care. Health Care Professionals were instructed to determine if they or their patients have affected meters by obtaining the lot number printed on the side of the Product's box or locating the meter's serial number on the back of the meter. Call Trividia Health Customer Care Department to determine if they or their patients have affected Product. Process affected meters per normal return procedures through the respective distributor. Advise patients to contact Trividia Health Customer Care Department to return affected units. Patients are asked to return the affected units directly to their pharmacy or place of purchase for replacement or contact Trividia Health Customer Care. Diabetes users were instructed to determine whether any affected meters are on hand in the same manner as health care professionals. Then call Trividia Health Customer Care Department to determine if affected Product and arrange for its return. Return the affected Product directly to your pharmacy or place of pu

Recall details

Recall number
Z-0413-2026
Status
Open, Classified
Initiated by the company
Oct 7, 2025
Posted by the FDA
Oct 30, 2025
Recalling firm
Trividia Health, Inc.
Quantity
601 units
Product code
NBW
FDA submissions
K140100
Distribution
US Nationwide distribution in the states of NY, VA, FL, OH, CA, KY, NC.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (7k characters)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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