{ "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": 46 } }, "results": [ { "cfres_id": "209985", "product_res_number": "Z-0022-2025", "event_date_initiated": "2024-08-26", "event_date_posted": "2024-10-08", "recall_status": "Open, Classified", "res_event_number": "95326", "product_code": "JLW", "k_numbers": [ "K052301" ], "product_description": "FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer", "code_info": "UDI-DI: 00816467020099, Lot: 2405017-1, Expiration: 2025-05-15", "firm_fei_number": "3003355251", "recalling_firm": "Qualigen Inc", "address_1": "2042 Corte Del Nogal", "address_2": "Ste B", "city": "Carlsbad", "state": "CA", "postal_code": "92011-1438", "additional_info_contact": "Erin Hoffman\n760-918-9165", "reason_for_recall": "Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher than expected.", "root_cause_description": "Nonconforming Material/Component", "action": "On 8/26/24, correction notices were emailed to customers who were asked to do the following: \n\n1) Dispose of affected TSH calibration cards.\n2) Use TSH Calibration Card Lot Number 2405017-1R sent with correction notices.\n3) Run TSH Quality Control samples.\n4) Review and retest any affected TSH results that may have been higher than expected.\n5) Notify all relevant parties within your organization or any organization that received the affected devices.\n6) Complete and return response forms via email to systemsupport@qualigeninc.com \n\nIf you have any questions regarding this matter, contact System Support Specialists at systemsupport@qualigeninc.com or (877) 709-2169, option 2.", "product_quantity": "60", "distribution_pattern": "US: TX, MS, NY, OH, MT, WA, PA, MN, SC, GA, NC, NV, WY, AK, SD, KS, NE, VT, AL, MA, OK, UT, WI, IA, WV.\n\nOUS: Germany, Switzerland", "openfda": { "k_number": [ "K141999", "K792562", "K941146", "K792154", "K781170", "K771590", "K931061", "K860054", "K890802", "K951796", "K983442", "K170232", "K903311", "K851329", "K871505", "K934410", "K171103", "K885157", "K854379", "K933212", "K843281", "K990993", "K874061", "K832813", "K153651", "K781150", "K780059", "K900014", "K791855", "K930776", "K830036", "K760801", "K771222", "K781296", "K922736", "K952148", "K801691", "K063437", "K890579", "K800798", "K222116", "K760132", "K852438", "K083844", "K935119", "K870320", "K843395", "K811431", "K843545", "K910411", "K870244", "K881443", "K910837", "K873303", "K081074", "K771767", "K772192", "K081543", "K023093", "K905710", "K811558", "K801560", "K881627", "K151792", "K771234", "K791217", "K920856", "K001455", 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"8020790", "3011989923", "3015969360", "3009711478", "3007349751", "3014279513", "3010324880", "1319681", "3043127647", "3004192065", "9680746", "1319808", "3003917514", "3002809144", "1061124", "3005360469", "3004434309", "3009518015", "2029372", "3005094123", "3012073813", "3009092698", "3006677029", "1317202", "3020917535", "9610126", "2250051", "8031673", "9614673", "3027519599", "2020726", "9610240", "9615037", "1063851", "1827821", "2517506", "2032087", "3050015", "1219913", "3010421384", "3003795116", "1319809", "1036362", "2032839", "9613959", "8043909", "3007111389", "3002642396", "3005984081", "8020888", "3009491259", "3003030793", "3005655287", "3005333358", "2030633", "3002637618", "3010825766", "3002806944", "3033967997", "2432235", "3000308930", "3006198300", "2122870", "3008583799", "3022178699", "3002800697", "3005529799", "1832216" ], "fei_number": [ "2050012", "3004185580", "2245285", "3002808328", "3012963943", "3005670738", "3003952975", "3011989923", "3015969360", "3009711478", "3007349751", "3014279513", "3010324880", "3004192065", "3043127647", "1000305840", "3003917514", "3002809144", "3004434309", "3009518015", "3005094123", "3012073813", "3009092698", "3006677029", "1317202", "3020917535", "2250051", "3002808301", "2967", "2020726", "3027519599", "1827821", "3002806559", "2517506", "3003261083", "3050015", "1219913", "1000512168", "3010421384", "3003795116", "1036362", "1000136573", "1000305841", "1000306617", "3007111389", "3005984081", "3002642396", "3009491259", "3003030793", "1000206808", "3005655287", "3005333358", "3002637618", "3010825766", "3002806944", "3002808498", "3033967997", "3007019572", "2432235", "3002808212", "1000442352", "1000611339", "3003559576", "3006198300", "3000308930", "2122870", "3008583799", "3022178699", "3002800697", "3005529799", "1832216", "3003355251", "3000210620" ], "device_name": "Radioimmunoassay, Thyroid-Stimulating Hormone", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1690", "device_class": "2" } } ] }