{ "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": 1 } }, "results": [ { "cfres_id": "219498", "product_res_number": "Z-1947-2026", "event_date_initiated": "2026-03-27", "event_date_posted": "2026-04-29", "recall_status": "Open, Classified", "res_event_number": "98697", "product_code": "LRR", "product_description": "AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, including single use indications, is maintained for each device, which may be used independently and at different times. These specific kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that were recalled as part of RES 98317 with (510(k): K140100).", "code_info": "Kit REF/UDI-DI/Lot:\n85-4661/00842209132089/85-4661122024;\n85-4742/00842209133536/85-4742123024.\nMeter: UDI-DI: 20612479197217, all lots.", "firm_fei_number": "3005034064", "recalling_firm": "North American Rescue LLC.", "address_1": "35 Tedwall Ct", "city": "Greer", "state": "SC", "postal_code": "29650-4791", "additional_info_contact": "864-675-9800", "reason_for_recall": "Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error, which can lead to operator confusion when evaluating patients and a delay in appropriate treatment. This is a downstream recall of Trividia Health Class I, Recall Event ID 98317.", "root_cause_description": "Component design/selection", "action": "On 3/27/2026, correction notices were emailed to customers asking them to take the following actions:\n\nFor Health Care Professions: Notify your providers and patients who use the products. You may use the customer notice on page 5.\n\nFor Multiple Patient Facilities: Please post the notice provided on page 6 in areas where the Products are stored within your facility to notify personnel of this labeling correction.\n\nFor People with Diabetes: Follow the updated E-5 error code instructions in the notice on page 5. \n\nThis correction should be carried out to the user level. If you have further distributed this product, notify them of this correction. Your notification may be enhanced by including this correction notification letter.\n\nCustomers with questions can contact Trividia Health Customer Care at 1-888-835-2723, Monday-Friday 8AM-8PM EST (excluding holidays) or email. For links to the updated Owner's Booklets and help resources visit www.trividiahealth.com trividia0126CC@trividiahealth.com\n\nThe notice provides email www.NARercue.com", "product_quantity": "21", "distribution_pattern": "US: CA, WA", "openfda": { "k_number": [ "K964029", "K952561", "K891483", "K941311", "K871501", "K841900", "K871376", "K940249", "K931634", "K921762", "K931058", "K871457", "K895767", "K903393", "K896413" ], "registration_number": [ "3007307589", "3002801783", "2214133", "3012314549", "3003960560", "1038758", "3008258694", "3014679991", "3005012805", "3006140792", "3008808560", "3003125988", "3013525704", "3004950768", "3007048929", "3017591173", "1932902", "3014620201", "3016050930", "3004519921", "3005083505", "3025413691", "3015821396", "3013034812", "3016763307", "1925025", "3015140351", "3015062266", "2124143", "8043323", "3045526618", "3011248163", "3020978033", "3010187918", "3042641002", "3006534724", "3015140199", "3012309743", "2111760", "3004993527", "3012024760", "3026263452", "3005034064", "3003911670", "3022568093", "3025309918", "3007187674", "3017482874", "3015745029", "3032597249", "2029439", "3030078769", "3012047311", "3027244997", "3002661124", "3008386507", "1644008", "3008808082", "3014680744", "1250045", "1000300091", "1036781", "3001106688", "3008427684", "3017162185", "2110420", "3015142851", "3005621808", "1000340275", "3006477788", "3008298053", "3004857344", "3007838093", "3021282544", "1121142", "2523099", "3010192494", "3010700223", "3014449454", "3035365737", "3015058854", "3016450032", "3002714597", "3012777736", "2133432", "9680884", "3012034017", "1025972", "3014296928", "3017299525", "3030017177", "3004704697", "9710583", "3013632692", "3023339256", "3013545043", "1320537", "3034605486", "3012104670", "3012711490", "3011862887", "3020460367", "3008384335", "3003866267", "3009095935", "3026041900", "3004018264", "3003807757", "3007689758", "3019111927", "3003698793", "2435946", "3003896222", "3006802076", "1000137876", "1928237", "3038637162", "3005761322", "9680934", "3008436219", "3027556696", "3012261738", "3011923964", "3015997711", "2416465", "3023917", "3004468406", "3011089435", "1417592", "3011247798", "3003887292", "3021035729", "1420763", "3040362701", "3011505386", "3012723641", "3045078803", "3009540516", "3030595978", "1422634", "3009547973", "3015173212", "3012311599", "3011280379", "3003206812" ], "fei_number": [ "3007307589", "3009964652", "3002801783", "2214133", "3012314549", "3003960560", "1038758", "1030186", "1000137528", "3008258694", "3014679991", "3005012805", "3006140792", "3003125988", "3013525704", "3004950768", "3007048929", "3010687142", "3017591173", "3004601847", "3014620201", "3016050930", "3003514271", "3005083505", "3025413691", "3015821396", "3013034812", "3016763307", "1000111918", "3015140351", "3015062266", "2124143", "3045526618", "3011248163", "3020978033", "3010187918", "3042641002", "3006534724", "3015140199", "3012309743", "2111760", "3002703161", "3004993527", "3012024760", "3026263452", "3005034064", "3003911670", "3022568093", "3025309918", "3007187674", "3017482874", "3015745029", "3032597249", "1000118065", "3030078769", "3012047311", "3027244997", "3002661124", "3008386507", "3008808082", "3014680744", "1250045", "1000300091", "3001106688", "3008427684", "3017162185", "2110420", "3015142851", "3005621808", "1000340275", "3006477788", "3008298053", "3004857344", "3007838093", "3021282544", "1121142", "2523099", "3010192494", "3010700223", "3014449454", "3035365737", "3015058854", "3016450032", "3002714597", "3012777736", "3012034017", "3014296928", "3017299525", "3030017177", "3004704697", "3013632692", "3023339256", "3013545043", "3034605486", "3012104670", "3012711490", "3011862887", "3020460367", "3008384335", "3003866267", "3006993165", "3009095935", "3026041900", "3004018264", "1000158435", "3003807757", "3007689758", "3019111927", "3003698793", "3005846326", "3006802076", "1000137876", "1928237", "3006078362", "1000117494", "3038637162", "3005761322", "3008436219", "3027556696", "3012261738", "3011923964", "3015997711", "1833338", "2416465", "3023917", "3004468406", "3011089435", "1417592", "3011247798", "3003887292", "1000514656", "3021035729", "3040362701", "3011505386", "3014534", "3045078803", "3009540516", "3030595978", "3009547973", "3015173212", "1000520824", "3000215374", "3012311599", "3011280379", "3003206812" ], "device_name": "First Aid Kit With Drug", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "N" } } ] }