{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "191897", "product_res_number": "Z-0716-2022", "event_date_initiated": "2022-01-13", "event_date_created": "2022-03-10", "recall_status": "Open, Classified", "res_event_number": "89539", "product_code": "QKP", "product_description": "LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)", "code_info": "Part Number: I-114(S)\nLot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)", "firm_fei_number": "3004473533", "recalling_firm": "Lusys Laboratories, Inc.", "address_1": "7220 Trade St Ste 338 7220 Trade St", "address_2": "Ste 338", "city": "San Diego", "state": "CA", "postal_code": "92121-2324", "additional_info_contact": "james Lu\n858-733-2128", "reason_for_recall": "COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.", "root_cause_description": "No Marketing Application", "action": "On 01/13 and 24/2022, the firm sent an \"URGENT MEDICAL DEVICE RECALL\" Letter via certified US Mail to customer informing them that the COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests are being recalled because these tests have not received FDA Emergency Use Authorization, nor have these test been cleared or approved by FDA for commercial distribution. Therefore, these tests cannot be legally marketed or distributed in the U.S., nor can they be legally exported from the U.S.. Because the abovementioned products were not authorized, cleared, or approved by\nFDA, the performance characteristics of these tests have not been adequately\nestablished, might presenting a high risk of false positive and false negative results.\n\nCustomers are instructed to:\n1. Immediately discontinue to use these tests.\n2. If your firm has distributed these products, immediately provide all consignees\nwith a copy of this recall notification.\n3. Discard or destroy all COVID-19 tests manufactured or distributed by LuSys\nLaboratories, Inc., a.k.a. Luscient Diagnostics LLC, or return the tests to the\nfollowing address: 7220 Trade Street, Suite 338, San Diego, CA, 92121, before\nJanuary 30, 2022.\n\nFor further questions regarding this Recall:\n-Call Telephone Number - 858-733-2128, or\n-email onestep@lusyslab.com", "product_quantity": "14,745 kits", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of CA, NC, NV, OH, TN and TX. The countries of Canada, China, and Mexico.\n\nPending additional information for a complete Consignee Listing", "openfda": { "registration_number": [ "3016837106", "3005360469", "3012516456", "3008054239", "3014022295", "3008925277", "3015883679", "3009238284", "3016610313", "9610126", "3020964039", "3028746593", "3004142665", "3011522054", "3000308930", "1000115322", "3023372670", "3018187017", "3020305857", "3016850770", "3008959428", "3009963993", "3022474803", "3008825965", "3033507883", "1219913", "2030538", "3032562", "3011561946", "3027500452", "3014660585", "3009014878", "3013160357", "3012133212", "3017171515", "3028107593", "2032682", "9610240", "3025041446", "3024756665", "3033751096", "3005984081", "3007111389", "3039322300", "3010934853", "3026478116", "3014654360", "2025099", "3039321686", "3043128348", "2432235", "3014862351", "3026664926", "3002821211", "3003297763", "3004181896", "3016761091", "3021090658", "3002792284", "3026565854", "3003896222", "3023947183", "3016820006", "1221359", "3027518847", "2250051", "2246703", "3017887566", "3002642396", "3004146366", "3008573045", "3017662853", "2020808", "1122236", "1319681", "3008517993", "3021082896", "2029372", "1313700", "3012963943", "3026478115", "3017894300", "2024674", "2431980" ], "fei_number": [ "3016837106", "3012516456", "3008054239", "3014022295", "3015883679", "3009238284", "3016610313", "3020964039", "3002606748", "3028746593", "3004142665", "3011522054", "3000308930", "1000115322", "3023372670", "3018187017", "3020305857", "3016850770", "3008959428", "3009963993", "3022474803", "1000520007", "3008825965", "3033507883", "1219913", "3011561946", "3027500452", "3014660585", "3009014878", "3013160357", "3002808212", "3012133212", "3004069780", "3017171515", "3028107593", "1000136573", "3025041446", "3024756665", "3033751096", "3005984081", "3007111389", "3039322300", "3010934853", "3026478116", "3014654360", "3039321686", "3043128348", "2432235", "3014862351", "3026664926", "3002821211", "3003297763", "3004181896", "3016761091", "3021090658", "3002792284", "3026565854", "3007981058", "3023947183", "3016820006", "1221359", "3027518847", "3010687142", "3002806559", "2250051", "2246703", "3017887566", "3002642396", "3004146366", "3008573045", "3017662853", "2020808", "1122236", "3008517993", "3021082896", "3003952975", "1313700", "3012963943", "3026478115", "3005670738", "3017894300", "2024674", "2431980", "1000306617" ], "device_name": "Coronavirus Antigen Detection Test System.", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "N" } } ] }