Z-0413-2026Class II

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

Name: Z-0413-2026 Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01
Creator: Trividia Health, Inc.
Published: 2025-10-07
License: https://open.fda.gov/license/

Trividia Health, Inc. / initiated 2025-10-07 / Open, Classified / root cause: design

FDA source

Trividia Health, Inc. began a recall of Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01 on 2025-10-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0413-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-07
Posted: 2025-10-30
Recalling firm: Trividia Health, Inc.
Product: Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.
Product code: NBW System, Test, Blood Glucose, Over The Counter
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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
Quantity in commerce: 601 units
Distribution: US Nationwide distribution in the states of NY, VA, FL, OH, CA, KY, NC.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0413-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0413-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-30

Product code NBW

K140100Class IITrue Metrix Self-Monitoring Blood Glucose System, True Metrix Pro Professional Monitoring Blood Glucose SystemNipro Diagnostics, Inc. / cleared 2014-08-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)