{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "218234", "product_res_number": "Z-1545-2026", "event_date_initiated": "2026-02-06", "event_date_posted": "2026-03-12", "recall_status": "Open, Classified", "res_event_number": "98317", "product_code": "NBW", "k_numbers": [ "K140100" ], "product_description": "Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item:\nWalgreens TRUE METRIX Kit/RE4001-01,\nLeader TRUE METRIX Kit/RE4002-01,\nLeader TRUE METRIX Meter Only/RE4002-40,\nCVS TRUE METRIX Kit/RE4007-01SB,\nGNP TRUE METRIX Meter Only/RE4011-00,\nGNP TRUE METRIX Kit\t/RE4011-01,\nMEIJER TRUE METRIX Kit/RE4019-01,\nFRED'S TRUE METRIX Kit/RE4023-01,\nDISCOUNT DRUG TRUE METRIX Kit/RE4025-01,\nKINRAY TRUE METRIX Kit/RE4027-01,\nHEB TRUE METRIX Kit/RE4031-01,\nMcKesson TRUE METRIX Starter Kit/RE4051-43,\nSUNMARK TRUE METRIX Meter Only/RE4054-00,\nSUNMARK TRUE METRIX Kit/RE4054-01,\nSignature Care TRUE METRIX Kit/RE4060-01,\nCareOne TRUE METRIX Kit/RE4061-01,\nRITE AID TRUE METRIX Kit/RE4066-01,\nLiberty TRUE METRIX Meter Only/RE4078-40,\nHUMANA TRUE METRIX Starter Kit/RE4081-03,\nWegmans TRUE METRIX Kit/RE4087-01,\nHEALTHMART TRUE METRIX Meter Only/RE4089-00,\nHEALTHMART TRUE METRIX Kit/RE4089-01,\nARRIVA TRUE METRIX Meter Only/RE4095-40,\nHealthyAccents TRUE METRIX Kit/RE4097-01,\nShopko TRUE METRIX Kit/RE4098-01,\nHenry Schein TRUE METRIX Kit/RE4099-40,\nHenry Schein TRUE METRIX Meter Only/RE4099-45,\nMillennium Pharmay Services TRUE METRIX Kit/RE4202-43,\nKroger TRUE METRIX Kit/RE4203-01,\nTOPCARE TRUE METRIX Kit/RE4209-01,\nFoster and Thrive TRUE METRIX Kit/RE4211-01,\nTRUE METRIX Meter Only/RE4H01-00,\nTRUE METRIX Kit/RE4H01-01,\nTRUE METRIX Starter Kit/RE4H01-04,\nTRUE METRIX NFRS Meter Only/RE4H01-40,\nTRUE METRIX NFRS Starter Kit/RE4H01-43,\nTRUE METRIX Kit/RE4H01-51,\nTRUE METRIX Meter Only (mg/dL)/RE4i01-00,\nTRUE METRIX Kit (mg/dL)/RE4i01-01,\nTRUE METRIX Kit (mg/dL)/RE4i01-02,\nTRUE METRIX Starter Kit (mg/dL)/RE4i03-02,\nTRUE METRIX Kit (mmol/L)/RE4i03-11,\nFarmacia Benavides TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i05-00,\nFarmacia del Ahorro TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i07-00,\nTRUE METRIX Meter Only (Mexico - mg/dL)/RE4i23-00,\nTRUE METRIX Meter Only (Jamaica - mmol/L)/RE4i29-11,\nTRUE METRIX Kit (mg/dL)/RE4i61-02,\nTRUE METRIX Kit (mg/dL)/RE4i61-02THI,\nTRUE METRIX Kit (United Kingdom - mmol/L)/RE4i82-11,\nTRUE METRIX Starter Kit (United Kingdom - mmol/L)/RE4i82-12.", "code_info": "Device Item/UDI-DI: RE4001-01/00311917166896, RE4002-01/96295126600, RE4002-40/96295126655, RE4007-01SB/50428275283, RE4011-00/87701426520, RE4011-01/87701426254, RE4019-01/713733069816, RE4023-01/21292007256, RE4025-01/93351018992, RE4027-01/21292007065, RE4031-01/41220001286, RE4051-43/20612479197231, RE4054-00/10939722447, RE4054-01/10939719447, RE4060-01/321130788669, RE4061-01/41520147745, RE4066-01/11822445610, RE4078-40/21292007614, RE4081-03/21292014797, RE4087-01/77890394113, RE4089-00/52569138557, RE4089-01/52569138526, RE4095-40/21292007041, RE4097-01/725439988933, RE4098-01/21292008901, RE4099-40/21292014902, RE4099-45/21292008697, RE4202-43/21292007454, RE4203-01/41260016028, RE4209-01/36800234529, RE4211-01/10939958693, RE4H01-00/21292006082, RE4H01-01/21292006051, RE4H01-04/21292008895, RE4H01-40/21292006068, RE4H01-43/21292006075, RE4H01-51/21292014940.\n\nInternational: RE4i01-00/N/A, RE4i01-01/N/A, RE4i01-02/N/A, RE4i03-02/N/A, RE4i03-11/N/A, RE4i05-00/N/A, RE4i07-00/N/A, RE4i23-00/21292010133, RE4i29-11/N/A, RE4i61-02/N/A, RE4i61-02THI/N/A, RE4i82-11/21292012205, RE4i82-12/21292009977.\n\nOwner's Booklet or IFU Description/Part and Revision:\nTRUE METRIX Owner's Booklet/ RE4TVH03 Rev 56 and prior,\nTRUE METRIX Owner's Booklet (English)/ RE4TVH35 Rev 51 and prior, \nTRUE METRIX Owner's Booklet (Spanish)/ RE4TVH35S Rev 51 and prior, \nMcKesson Med Surg TRUE METRIX Self Monitoring Owners Booklet/ RE4SUN03 Rev 55 and prior, \nMcKesson Med Surg TRUE METRIX PRO Owners Booklet/ RE4SUNP03 Rev 56 and prior, \nTRUE METRIX Blood Glucose Monitoring System IFU Trividia House Brand/ RE4ITV16 Rev 53 and prior, \nTRUE METRIX System Instructions for Use (IFU) for Trividia Health UK Limited/RE4UKT16 Rev 55 and prior, \nTrividia Health LATAM - TRUE METRIX System IFU mg/dL/ RE4LAT16 Rev 50 and prior, \nTRUE METRIX System Instructions for Use (IFU) for Trividia Health Australia/ RE4AUT16 Rev 56 and prior.\n\nDevice serial numbers: Prefix \"T\" followed by an eight-digit numeric sequence.", "firm_fei_number": "1000113657", "recalling_firm": "Trividia Health, Inc.", "address_1": "2400 Nw 55th Ct", "city": "Fort Lauderdale", "state": "FL", "postal_code": "33309-2672", "additional_info_contact": "Annmarie Ramos\n954-677-9201", "reason_for_recall": "The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.", "root_cause_description": "Software design", "action": "On 2/6/2026, press was issued and correction notices were emailed to customers. \n\nE-5 Error Code in the Messages section of the Owner's Booklets/System Instructions for Use emphasizes that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose. \n\nCustomers: notify your customers immediately of the correction and to include the letter in their notification, and to ask that they notify their customers or facilities if they have further distributed the Products. \n\nRetail pharmacies: post the notice in areas where the Products are sold to notify patients. \n\nMultiple Patient Facilities: post the notice in areas where the Products are stored to notify personnel.\nPeople with Diabetes are asked to follow the updated E-5 error code instructions Visit www.trividiahealth.com for updated Owner's Booklets and help resources. \n\nComplete and return the acknowledgement form via email to trividia0126CS@trividiahealth.com \n\nFirm Customer Care Department: 1-888-835-2723, trividia0126CC@trividiahealth.com or visit www.trividiahealth.com/E-5productnotice , which has links to Owner's Booklets, correction notice, and press.\n\nOn 5/5/2026, updated correction notices were mailed to customers informing them of the following:\nFor people with diabetes, if possible, consider transitioning to an alternative method of testing your blood glucose. People with Diabetes who rely on intensive insulin therapy, sulfonylureas, or glucose monitoring due to frequent hypo- or hyperglycemia events should consider transitioning to an alternative testing method until the updated devices with updated software becomes available. Firm will notify users when the upgrade program becomes available. The firm asked customers to handle dissemination of the updated notice and completion/return of the acknowledgement form as stated above. Affected serial number search tool is located at www.trividiahealth.com/E-5productnotice", "product_quantity": "12,067,458", "distribution_pattern": "Worldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia.", "openfda": { "k_number": [ "K201396", "K151658", "K090495", "K052208", "K130886", "K133741", "K072489", "K091765", "K203711", "K102678", "K141036", "K081450", "K032552", "K090389", "K071507", "K102751", "K080538", "K150299", "K123016", "K022545", "K140100", "K140325", "K190564", "K213887", "K151611", "K111456", "K053312", "K120708", "K161790", "K133522", "K063771", "K051802", "K080014", "K081144", "K120866", "K192859", "K063068", "K160430", "K241304", "K020866", "K072854", "K131419", "K250085", "K041750", "K103542", "K130265", "K130284", "K130138", "K094005", "K113137", "K062187", "K133509", "K132929", "K022724", "K170267", "K223722", "K022182", "K171822", "K093262", "K083263", "K170064", 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"K160944", "K023832", "K062195", "K150332", "K062235", "K090187", "K113135", "K090653", "K120813", "K020208", "K181273", "K141829", "K193407", "K093930", "K123007", "K123010", "K182428", "K062829", "K071493", "K131230", "K043311", "K181527", "K023219", "K143467", "K181070", "K130295", "K072905", "K193475", "K072039", "K100322", "K132406", "K060620", "K082521", "K101597", "K090628", "K202885", "K083468", "K102816", "K130696", "K113192", "K122370", "K063026", "K081318", "K061118", "K053529", "K162203", "K182057", "K101926", "K081703", "K090332", "K112638", "K193406", "K233058", "K200277", "K103021", "K132072", "K160282", "K090185", "K113343", "K182046", "K112916", "K080641", "K123090", "K070255", "K101509", "K043543", "K070053", "K170264", "K173658", "K193590", "K130094", "K101631", "K091898", "K041107", "K153278", "K070559", "K060793", "K011616", "K082328", "K161299", "K052108", "K181588", "K152599", "K140141", "K051936", "K160682", "K240640", "K130244", "K090188", "K141656", "K160742", "K012975", "K040678", "K053593", "K030703", "K091820", "K090536", "K070850", "K121133", "K092052", "K222126", "K100560", "K093475", "K042795", "K110737", "K131469", "K220421", "K082020", "K010403", "K173511", "K083273", "K181131", "K153561", "K170464", "K082201", "K060467", "K051854", "K132272", "K140210", "K062377", "K131029", "K180866", "K132862", "K123517", "K132338", "K072543", "K150274", "K113098", "K091168", "K131013", "K103544", "K131173", "K103044", "K062567", "K170079", "K113614", "K202739", "K120064", "K093755", "K050500", "K090405", "K042005", "K191286", "K150817", "K081451", "K062538", "K073699", "K092894", "K142928", "K070088", "K183306", "K031843", "K072413", "K080923", "K020210", "K081715", "K031501", "K172723", "K040628", "K111509", "K243060", "K042678", "K190579", "K160179", "K142035", "K213061", "K151100", "K102049", "K191657", "K102481", "K110017", "K023256", "K022581", "K011240", "K223293", "K082486", "K062555", "K070585", "K032657", "K231476", "K072274", "K063409", "K073231", "K071393", "K201037", "K173505", "K150052", "K073573", "K062347", "K083099", "K122142", "K192220", "K012324", "K080501", "K091157", "K150833", "K210687", "K170231", "K070524", "K130621", "K101543", "K091481", "K091815", "K140068", "K061328", "K140371", "K121087", "K080853", "K150396", "K143387", "K070641", "K072784", "K081975", "K102345", "K062800", "K012205", "K012014", "K123087", "K133045", "K090404", "K063212", "K033845", "K050224", "K012210", "K133790", "K231192", "K090057", "K024234", "K043340", "K032029", "K171785", "K152534", "K072054", "K060470", "K222234", "K110435", "K112738", "K010039", "K082169", "K122307", "K102063", "K124040", "K171941", "K162564", "K051147", "K161738", "K031260", "K081957", "K121679", "K133389", "K040670", "K260545", "K062770", "K190189", "K102383", "K112275", "K160365", "K080710", "K143169", "K092902", "K092875", "K151164", "K073137", "K093635", "K014167", "K160038", "K170143" ], "registration_number": [ "2531491", "1066444", "3015109923", "3042026207", "3010852191", "3005627859", "3011213605", "3013729860", "3007031103", "3010622184", "3004167884", "3007384659", "2954323", "3022147580", "3045951983", "3043025312", "1000115322", "3008606429", "3014353121", "3012133212", "3009204541", "3011420269", "1616487", "3004043187", "1832816", "3043513123", "3008810357", "3005644014", "3013957847", "3022346573", "3010564249", "3016525500", "3011061417", "3011536730", "3012421607", "1220477", "1649661", "3015489159", "9610126", "3008789114", "3012118659", "3034603279", "3015188281", "3016863723", "3003366417", "3018940143", "3021286079", "3012188053", "3004009431", "3005862821", "3024379416", "3017550662", "1000134386", "3003917514", "3012014399", "3013298431", "3006733253", "3011121740", "3033394445", "9615507", "3011979858", "3005621222", "3014302067", "3004637226", "3004539335", "3043013796", "3009129531", "1220649", "3003132490", "3009901017", "3007594734", "3006537560", "3005798905", "3010830834", "3042301847", "3003674698", "3002807314", "9612841", "3007382160", "3017548799", "3008382007", "9710492", "3007363438", "3015347724", "3020976354", "3003902721", "9616936", "3008514395", "3003600763", "3004101980", "3005393828", "3015058854", "3007421145", "3021611414", "3013472743", "3008700497", "3038419886", "1832216", "3020885868", "1450662", "3003422726", "3010131137", "3045752480", "3008780388", "3012104670", "3004145393", "3026260647", "1450743", "3031789039", "3006371704", "3045492872", "3013896610", "3012725363", "3020460367", "3009456923", "3009171251", "3015525148", "3031259044", "3014353045", "3030311186", "3024512705", "3003741676", "3030978471", "9611444", "1037998", "3004130086", "9616530", "3008573045", "3004176168", "3017500903", "1181121", "3005706626", "3007134734", "1810909", "3032948391", "2953359", "3004146366", "3017520431", "3013223546", "3014585508", "3015997711", "3011393376", "3004183148", "2030633", "3011191255", "3030979885", "3011065399", "3004193489", "3017086896", "3008959428", "3033530347", "3008824097", "3005360469", "2029275", "3006532271", "3002736372", "1000113657", "9710595", "1219029", "3001058982", "3007710663", "3005395953", "3006755541", "3042364147", "3013160357", "3001452053", "3010713600", "3015967131", "3022418645", "3007499349", "3030186688" ], "fei_number": [ "3015109923", "3042026207", "3010852191", "3005627859", "3011213605", "3013729860", "3007031103", "3010622184", "3004167884", "3007384659", "3022147580", "3045951983", "3043025312", "1000115322", "3008606429", "3014353121", "3012133212", "3009204541", "3011420269", "1616487", "3004043187", "1832816", "3043513123", "3008810357", "3001451797", "3005644014", "3013957847", "3022346573", "3010564249", "3005664575", "3016525500", "3011061417", "3004525092", "3011536730", "3012421607", "1220477", "3015489159", "3008789114", "3012118659", "3034603279", "3015188281", "3016863723", "3003366417", "3018940143", "3021286079", "3003500908", "3012188053", "3000215205", "3004009431", "3005862821", "3002806559", "1000306431", "3024379416", "3017550662", "1000134386", "3003917514", "3012014399", "3013298431", "3006733253", "3033394445", "3000210620", "3011979858", "3005621222", "3014302067", "3004637226", "3004539335", "3043013796", "3009129531", "1220649", "3003132490", "3009901017", "3007594734", "3006537560", "3011774813", "3005798905", "3042301847", "3003674698", "3002807314", "3007382160", "3017548799", "3008382007", "3015347724", "3020976354", "3003902721", "3008514395", "3003600763", "3004101980", "3005393828", "3015058854", "3003400058", "3021611414", "3013472743", "3008700497", "3038419886", "1832216", "3020885868", "1450662", "3003422726", "3010131137", "3045752480", "3005670738", "3008780388", "3012104670", "3004145393", "3026260647", "1450743", "3031789039", "3006371704", "3045492872", "3013896610", "3012725363", "3020460367", "3009456923", "3002671736", "3004173703", "3031259044", "3014353045", "3002698769", "3030311186", "3024512705", "3003741676", "3002807423", "3030978471", "3002806387", "1037998", "3004130086", "3008573045", "3004176168", "3017500903", "1181121", "3005706626", "3007134734", "1810909", "3032948391", "3004146366", "3017520431", "3013223546", "3014585508", "3015997711", "3011393376", "3004183148", "3002829675", "3011191255", "3010700165", "3030979885", "3011065399", "3004193489", "3017086896", "3008959428", "3033530347", "3008824097", "3006759904", "3006532271", "1000113657", "3003516723", "1219029", "3001058982", "3003116995", "3005395953", "3006755541", "3002803444", "3042364147", "3013160357", "3004631140", "3001452053", "3010713600", "3003405786", "3015967131", "3022418645", "3030186688" ], "device_name": "System, Test, Blood Glucose, Over The Counter", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1345", "device_class": "2" } } ] }