{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 11 } }, "results": [ { "cfres_id": "216612", "product_res_number": "Z-1257-2026", "event_date_initiated": "2025-11-22", "event_date_posted": "2026-02-04", "recall_status": "Open, Classified", "res_event_number": "97801", "product_code": "LJX", "product_description": "LotFancy Urinary Tract Infection Urine (UTI) Test Strips;\nPALINOIA UTI-10 PARAMETER REAGENT STRIPS;\nVaunn Medical 8-in-1 Urinalysis Reagent Strip;\nJNW Direct 4-in-1 UTl Urinalysis Test Strips;\nUrinify STRENGTH;\nUrinify ESSENTIAL, \nUrinify Urinary Tract Infection (UTI)", "code_info": "Name/Lot(Expiration):\nLotFancy Urinary Tract Infection Urine (UTI) Test Strips/2025062001(06/19/2027);\nLotFancy URS-3N Test Strip/2025033101(03-30-2027), 2025080801(08-07-2027), 2025090844(09-07-2027);\nPALINOIA UTI-10 PARAMETER REAGENT STRIPS/2025042110(04-20-2027), 2025021001(02-20-2027);\nVaunn Medical 8-in-1 Urinalysis Reagent Strip/2024032508(03/24/2026), 2024071602(07/15/2026), 2024102108(10/20/2026);\nJNW Direct 4-in-1 UTl Urinalysis Test Strips/30D25WC(04/29/2027), 02D25WC(04/01/2027), 30E25WC(05/29/2027), 10H24WC(07/10/2026);\nUrinify STRENGTH/202403103-6(01/03/2026), 202504103-6(01/01/2027), 202505103-6(06/01/2027), 202504103-3(01/01/2027), 202505103-3(06/01/2027);\nUrinify ESSENTIAL/202403104-6(01/03/2026), 202504104-6(01/01/2027), 202505104-6(06/01/2027), 202504104-3(01/01/2027), 202505104-3(06/01/2027);\nUrinify Urinary Tract Infection (UTI)/202501105-5(01/02/2027)", "firm_fei_number": "3008987086", "recalling_firm": "Changchun Wancheng Bio-Electron Co., Ltd.", "address_1": "2336, Tianwei Road 2336 science and technology development zone tianwei road", "city": "Changchun", "state": "Beihu", "country": "China", "reason_for_recall": "Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.", "root_cause_description": "No Marketing Application", "action": "Starting on 11/22/2025, recall notices were mailed or emailed to customers/distributors who were asked to do the following:\n1) Destroy unused devices.\n2) Inform customers that test results may be inaccurate, and it is recommended to re-test.\n3) If affected devices were further distributed, please forward this notice and response form to these additional customers or email us a customer distribution list with names, emails, addresses, phone numbers so we can notify your customers of the recall.\n4) Complete and return the Acknowledgement and Receipt Form via email to: sales04@ccwancheng.com\n\nQuestions can be emailed to the firm at: sales01@ccwancheng.com / sales04@ccwancheng.com", "product_quantity": "91,366", "distribution_pattern": "US Nationwide distribution in the states of TX, GA, CA.", "openfda": { "k_number": [ "K231045", "K971976", "K981555", "K063295", "K873304", "K843727", "K000578" ], "device_name": "Test, Urine Leukocyte", "medical_specialty_description": "Hematology", "regulation_number": "864.7675", "device_class": "1", "registration_number": [ "3006198300", "3008517993", "1518939", "1719513", "2531491", "3020956494", "4580", "3030446844", "3024171133", "3003422726", "3017591220", "3010324880", "3013679502", "2122870", "3043127647", "1833387", "3016621374", "3008058135", "9610633", "1616487", "3006621318", "3005841640", "2432235", "1649661", "3010194621", "1221895", "3003791481", "3030648160", "3013167221", "3010891909", "2029372", "9611444", "3012421607", "1036362", "3038206980", "1832216", "1181121", "3004043187", "8040374", "2244821", "1417592", "3013545943", "9710094", "3004192065", "3031915160", "3007126977", "3009238284", "3009448641", "3013077867", "3003917514", "3027519599", "3012073813", "3003795116", "3010852191", "3005360469", "3021186226", "3018126397", "9610126", "3012187283", "3002637618", "3015729142", "3025041446", "3003896222", "3024463179", "2030633", "3012725363", "1061932", "9680746", "3015341499", "3011689956", "3048141116", "2028411", "3008987086", "3007301207", "9615507", "1832816", "3014759506", "3043127699", "3012494290", "3042471840", "3016609999", "3014255036", "3012706495", "3016712364", "3003741796" ], "fei_number": [ "3006198300", "3008517993", "1518939", "1719513", "3020956494", "4580", "1000125241", "3030446844", "3024171133", "3003422726", "3017591220", "3010324880", "3013679502", "2122870", "3043127647", "1833387", "3016621374", "3000210620", "3002806693", "3008058135", "1616487", "3006621318", "3005841640", "3000203293", "1000306617", "2432235", "3010194621", "1221895", "3003791481", "3030648160", "3013167221", "3003333011", "3010891909", "3012421607", "1036362", "3038206980", "1832216", "3001451797", "1181121", "3004043187", "2244821", "1417592", "3013545943", "3004192065", "3031915160", "3007126977", "3009238284", "3009448641", "5864", "3013077867", "3003917514", "1000206808", "3003516723", "3027519599", "3012073813", "3002806559", "3003795116", "3010852191", "3010687142", "3021186226", "3018126397", "3005670738", "3002637618", "3015729142", "3002829675", "3025041446", "3024463179", "3012725363", "3015341499", "3011689956", "3002807423", "3048141116", "3008987086", "3007301207", "1832816", "3014759506", "3003347234", "3043127699", "3012494290", "3042471840", "3016609999", "3014255036", "3012706495", "3016712364", "3003741796" ] } } ] }