{ "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": 2 } }, "results": [ { "cfres_id": "187082", "product_res_number": "Z-1619-2021", "event_date_initiated": "2021-04-26", "event_date_created": "2021-05-28", "recall_status": "Completed", "res_event_number": "87737", "product_code": "QKO", "product_description": "Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.", "code_info": "All Lots distributed within the U.S.", "firm_fei_number": "3008002401", "recalling_firm": "LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD", "address_1": "Building 7-1 7-1 no. tech zone 37 chaoqian rd", "city": "Beijing", "country": "China", "reason_for_recall": "Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not authorized, cleared, or approved for marketing and/or distribution in the U.S.", "root_cause_description": "No Marketing Application", "action": "On 4/26/2021, Lepu Medical issued an \"Urgent: Medical Device Recall Notification\" to all affected consignees. In addition, to informing consignees about the recall, Lepu asked consignees to take the following actions:\n\n(1)\tQuarantine and discontinue distribution of All Lots of the abovementioned products which were distributed to U.S.\n\n(2)\tPlease complete the acknowledgement form and send to recall@lepu-medical.com within 5 business days. If you no longer have any of the recalled product, please also complete the acknowledgement form and return to us by email above.\n\n(3)\tIf your firm has distributed the product, please provide all consignees with a copy of the recall notification. Please also identify the lots and quantities of products shipped to U.S. within the acknowledgement form. \n\n(4)\tWe request you to remove the products from U.S. within 30 working days or contact us to discuss the solution. Please provide your intent and actions taken to remove remaining product from the US market.\n\nDisposal of Products\n\n5. All Lots of the abovementioned products which were distributed to U.S. shall be removed from the U.S. market. Please either remove the products from U.S. within 30 working days. Please contact us immediately to assist with the removal of the products within the 30-working day requirement.\n\n6. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax:\n\"\tComplete and submit the report Online: www.fda.gov/medwatch/report.htm\n\"\tRegular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.\n\n7. Should you have any further questions, please feel free to contact recall@lepu-medical.com", "product_quantity": "8, 419, 545 units in total", "distribution_pattern": "Worldwide Distribution: US Distribution to states of: FL, IL, NY, GA, Puerto Rico and OUS countries of: Canada, Honduras, Peru, Dominican, Bolivia, Colombia,\nMexico, Brazil, Argentina, Guatemala, Venezuela, Ecuador, Chile, Paraguay, Panama, Costa Rica, Peru and Hong Kong.", "openfda": { "device_name": "Reagent, Coronavirus Serological", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "N", "registration_number": [ "3007118747", "3009092698", "3005333358", "8023060", "3017379203", "3013530901", "3010934853", "3016761091", "3014022295", "3024756665", "3011522054", "1319681", "3002792284", "3007361513", "2031229", "3003917514", "3016820006", "3013332582", "2431980", "1832216", "3014862351", "2250051", "3012963943", "2242436", "3007111389", "9610240", "2032682", "3026664926", "2521625", "3016610313", "2032900", "3026565854", "3002642396", "3038560224", "3016850770", "1415939", "3008344661", "3009585529", "3010610113", "2020726", "3008517993", "3005094123", "3007349751", "3032562", "3003795116", "3033507883", "3012289707", "2182595", "2029372", "3009014878", "3003268355", "3009238284", "1318354", "1063851", "3035708936", "3005984081", "2025099", "3016764932", "3000308930", "9610126" ], "fei_number": [ "3007118747", "3009092698", "3005333358", "1000306617", "3004445302", "3017379203", "3013530901", "3010934853", "3002806559", "3016761091", "3014022295", "3011522054", "3024756665", "3002792284", "3007981058", "3007361513", "3003917514", "3016820006", "3013332582", "2431980", "1832216", "3014862351", "2250051", "3012963943", "2242436", "3007111389", "1000136573", "3002606748", "3026664926", "3000719950", "3016610313", "3026565854", "2521625", "3002642396", "3038560224", "3003992026", "3016850770", "1415939", "3008344661", "3009585529", "3010610113", "3002808212", "3003952975", "2020726", "3008517993", "3005094123", "3007349751", "3003795116", "3033507883", "3012289707", "2182595", "3009014878", "3003268355", "3009238284", "1318354", "3005984081", "3035708936", "1000442352", "3016764932", "3000308930" ] } } ] }