{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "186752", "product_res_number": "Z-1537-2021", "event_date_initiated": "2021-04-09", "event_date_created": "2021-06-10", "recall_status": "Open, Classified", "res_event_number": "87682", "product_code": "QKP", "product_description": "COVID-19 Self-Test Kit *** INNOVA *** 7T", "code_info": "Catalog Number: 7T Lot Numbers: U2101748 U2102001 U2102002 X2012711 X2103792", "firm_fei_number": "3018074194", "recalling_firm": "INNOVA MEDICAL GROUP, INC.", "address_1": "800 E Colorado Blvd Ste 200 800 E Colorado Blvd", "address_2": "Ste 200", "city": "Pasadena", "state": "CA", "postal_code": "91101-5401", "additional_info_contact": "Michael Malis\n626-239-0025", "reason_for_recall": "Due to distributing test kits to customers who were not part of a clinical investigation.", "root_cause_description": "No Marketing Application", "action": "On or about 04/26/2021, the firm sent an \"URGENT: MEDICAL DEVICE RECALL\" Notification via email to its customers informing them that it is recalling products that were distributed outside of a clinical investigation and that the affected products are for investigational use only. The performance characteristics have not been establish and the tests should not be used to screen or diagnose COVID-19. The negative results obtained on the tests are not indicator of the status of SARS-CoV-2 infection.\n\nCustomers are instructed to:\n-Check their inventory to see if they have in their possession the affected products.\n-If they have affected products, they are to count the test kits and write the number on the accompanying \"MEDICAL DEVICE RECALL RETURN RESPONSE\" form and return the form to the Recalling Firm via the provided FedEx envelope.\n-Destroy (by placing in your household waste) or return the affected products (Customer's choice), but to include the total number of destroyed and returned test on the \"MEDICAL DEVICE RECALL RETURN RESPONSE\" form.\n\nFor any questions or assistance, contact Linda Weinreb at Linda.Weinreb@innovamedgroup.com or 747-494-0852.", "product_quantity": "370 boxes (=2,590 individual tests)", "distribution_pattern": "Worldwide distribution - U.S. Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VA, VT, WA, and WI. The countries of Canada, India and United Kingdom.", "openfda": { "registration_number": [ "3018187017", "3008054239", "3016761091", "3002792284", "3011522054", "3004142665", "3016837106", "3014862351", "3017894300", "1122236", "3004181896", "3026478116", "3002642396", "3033751096", "2432235", "3023372670", "3009014878", "3009238284", "2246703", "3017887566", "3043128348", "3020305857", "3014654360", "3008573045", "1319681", "3021090658", "3015883679", "3016820006", "2431980", "3012963943", "3007111389", "2032682", "3008925277", "3026664926", "3008959428", "3014660585", "3016850770", "3003297763", "3005360469", "3008517993", "2020808", "3018786392", "2029372", "2025099", "3039321686", "9610126", "1313700", "3002821211", "3017662853", "3024756665", "3011561946", "3013160357", "2250051", "3004146366", "3016610313", "3012516456", "3021082896", "3027518847", "1000115322", "3032562", "3028746593", "3039322300", "3005984081", "1221359", "3003896222", "3023947183", "3028107593", "3020964039", "3012133212", "3026478115", "3010934853", "3014022295", "3022474803", "3027500452", "3025041446", "9610240", "3026565854", "3017171515", "3009963993", "2024674", "3033507883", "2030538", "3008825965", "1219913", "3000308930" ], "fei_number": [ "3018187017", "3008054239", "3016761091", "3002792284", "3011522054", "3004142665", "3016837106", "3014862351", "3017894300", "1122236", "3002606748", "3004181896", "3026478116", "3002642396", "3010687142", "3033751096", "2432235", "3023372670", "1000520007", "3009014878", "3009238284", "2246703", "3017887566", "3043128348", "3005670738", "3020305857", "3014654360", "3008573045", "3007981058", "3021090658", "3015883679", "3016820006", "3004069780", "2431980", "3012963943", "3007111389", "3026664926", "3008959428", "3014660585", "3016850770", "3003297763", "3003952975", "3008517993", "2020808", "3018786392", "3039321686", "1313700", "3002821211", "3017662853", "3002806559", "3024756665", "3011561946", "3013160357", "2250051", "3004146366", "3016610313", "3012516456", "3021082896", "3027518847", "1000115322", "3028746593", "3039322300", "3005984081", "1221359", "3023947183", "3028107593", "3020964039", "3012133212", "3026478115", "1000306617", "3010934853", "3014022295", "3022474803", "3027500452", "3025041446", "1000136573", "3026565854", "3002808212", "3017171515", "3009963993", "2024674", "3033507883", "3008825965", "1219913", "3000308930" ], "device_name": "Coronavirus Antigen Detection Test System.", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "N" } } ] }