{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "197445", "product_res_number": "Z-0929-2023", "event_date_initiated": "2022-11-28", "event_date_posted": "2023-01-27", "recall_status": "Open, Classified", "res_event_number": "91321", "product_code": "QKP", "product_description": "Products are labeled as:\n\nSkippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT\n\n\nGreen and white box under the brand DiagnosUS, \n\nand, \n\nWhite box without brand name labeled as \"SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING", "code_info": "Model Number: 550-10\nUDI Code: None\nLot Numbers:\nUL-AG-2111-01-Q\nUL-AG-2111-02-Q\nUL-AG-2110-05-Q\nUL-AG-2112-02-Q\nUL-AG-2110-03-Q\nUL-AG-2110-04-Q", "firm_fei_number": "3011908678", "recalling_firm": "Universal Meditech Inc.", "address_1": "1320 E Fortune Avenue, Suite 102 1320 E Fortune Avenue", "address_2": "Suite 102", "city": "Fresno", "state": "CA", "postal_code": "93725", "additional_info_contact": "Michael M. Lin\n702-871-9888", "reason_for_recall": "Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.", "root_cause_description": "No Marketing Application", "action": "On 12/29/2022, the firm sent an \"URGENT: MEDICAL DEVICE RECALL\" Letter via email to customers informing them Universal Meditech Inc. is recalling SARS-CoV-2 Antigen Rapid Test Kits due to test kits being distributed with any FDA pre-market approvals, clearances and/or authorizations. Test kits are labeled as:\nSkippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits, or\nlabelled and packaged in Green and white box under the brand name DiagnosUS, or \npackaged in White box without brand name labeled as \"SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING.\n\nCustomer are instructed to:\n-Immediately stop distributing or using any of the abovementioned device in their remaining stock.\n-If they have already distributed the device to anyone else, please inform them of the product recall by forwarding this letter to them.\n-Acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending back to Universal Meditech, so that arrangements can be made to refund or an order replacement using FDA authorized devices.\n\nNote- this recall is for ALL devices under this trade name, regardless of their lot number and date of manufacture.\n\nFor questions or assistance with this recall, contact Michael M. Lin, Legal Attorney\nEmail: m@linlawgroup.com or Tel: +1(702)871-9888 (9AM to 5PM, PST, MON to FRI)", "product_quantity": "56,300 kits", "distribution_pattern": "U.S. Nationwide distribution in the states of CA, and TX.", "openfda": { "registration_number": [ "3008925277", "3002792284", "3016850770", "2025099", "3003896222", "3017662853", "3014654360", "3016761091", "3025041446", "3021082896", "3003297763", "1319681", "3016837106", "3021090658", "2432235", "3017894300", "3013160357", "2431980", "3012516456", "1000115322", "3012963943", "3039321686", "2246703", "3022474803", "3043128348", "3008959428", "3014862351", "3004146366", "3016610313", "2030538", "3017171515", "3023947183", "3009963993", "2250051", "3026478116", "3002642396", "3023372670", "3024756665", "3015883679", "3014660585", "3018187017", "3026478115", "2024674", "3008573045", "3026664926", "3007111389", "3000308930", "1221359", "3010934853", "1313700", "3011522054", "3002821211", "9610240", "3028107593", "1219913", "3014022295", "3020964039", "3008054239", "3011561946", "3009238284", "3009014878", "3026565854", "3039322300", "3005984081", "3032562", "3020305857", "3033507883", "2020808", "3017887566", "3033751096", "3012133212", "3008825965", "3004142665", "3016820006", "3028746593", "3018786392", "3005360469", "3027518847", "9610126", "2029372", "2032682", "3004181896", "1122236", "3027500452", "3008517993" ], "fei_number": [ "3002792284", "3016850770", "3017662853", "3014654360", "3016761091", "3025041446", "3021082896", "3003297763", "3016837106", "3021090658", "2432235", "3017894300", "3013160357", "2431980", "3012516456", "1000115322", "3012963943", "3039321686", "2246703", "1000520007", "3007981058", "3043128348", "3022474803", "3008959428", "3014862351", "3004146366", "3016610313", "3017171515", "3002808212", "3023947183", "3009963993", "2250051", "3026478116", "3002642396", "3023372670", "3024756665", "3003952975", "3015883679", "3014660585", "3018187017", "3026478115", "2024674", "3010687142", "3008573045", "3026664926", "3007111389", "3000308930", "1221359", "3010934853", "1313700", "3011522054", "3002821211", "3005670738", "3028107593", "1219913", "3014022295", "3020964039", "3008054239", "1000136573", "3011561946", "1000306617", "3009238284", "3002806559", "3009014878", "3026565854", "3039322300", "3005984081", "3020305857", "3033507883", "2020808", "3002606748", "3017887566", "3033751096", "3012133212", "3008825965", "3004142665", "3016820006", "3028746593", "3018786392", "3027518847", "3004069780", "3004181896", "1122236", "3027500452", "3008517993" ], "device_name": "Coronavirus Antigen Detection Test System.", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "N" } } ] }