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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-0413-2026
Recalling firm
Trividia Health, Inc.
Product
Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.
Status
Open, Classified
Initiated
2025-10-07
Posted
2025-10-30
Terminated
not on file
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.
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
601 units
Distribution
US Nationwide distribution in the states of NY, VA, FL, OH, CA, KY, NC.
Lot, serial or model codes
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, 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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.
510(k) numbers
["K140100"]
PMA numbers
not on file
Product code
NBW
Firm FEI
1000113657
Firm city
Ft Lauderdale
Firm state
FL
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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