{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216486", "product_res_number": "Z-0413-2026", "event_date_initiated": "2025-10-07", "event_date_posted": "2025-10-30", "recall_status": "Open, Classified", "res_event_number": "97747", "product_code": "NBW", "k_numbers": [ "K140100" ], "product_description": "Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.", "code_info": "Model/Catalog Number: RE4011-01. UDI-DI (Meter Kit): 00087701426254. UDI-DI (Meter): 00021292007690. 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Expiration Date: 02/21/2030.", "firm_fei_number": "1000113657", "recalling_firm": "Trividia Health, Inc.", "address_1": "2400 Nw 55th Ct", "city": "Ft Lauderdale", "state": "FL", "postal_code": "33309-2672", "additional_info_contact": "Annmarie Ramos\n+1-800-3427226 Ext. 3190", "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_description": "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. \n\nPharmacists/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. \n\nHealth 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. \n\nDiabetes 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", "product_quantity": "601 units", "distribution_pattern": "US Nationwide distribution in the states of NY, VA, FL, OH, CA, KY, NC.", "openfda": { "k_number": [ "K121087", "K083628", "K100322", "K090332", "K222234", "K052343", "K170267", "K182286", "K123010", "K173658", "K070524", "K093755", "K171822", "K101457", "K190189", "K062347", "K111932", "K073699", "K092902", "K080641", "K160282", "K150052", "K093475", "K132072", "K112638", "K032657", "K182047", "K090188", "K123136", "K060470", "K021827", "K203562", "K033845", "K051839", "K100806", "K050224", "K092099", "K014099", "K073137", "K103396", "K183306", "K130138", "K032029", "K053529", "K141862", "K133509", "K092602", "K073573", "K150274", "K070255", "K050500", "K181070", "K131469", "K063212", "K090404", "K103329", "K082486", "K151100", "K152493", "K182428", "K072369", "K021819", "K140068", "K132086", "K133741", "K103115", "K080923", "K111029", "K140100", "K141036", 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