{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "195858", "product_res_number": "Z-0071-2023", "event_date_initiated": "2022-08-12", "event_date_posted": "2022-10-08", "recall_status": "Open, Classified", "res_event_number": "90800", "product_code": "JSM", "product_description": "COVID Test Kit Nonsterile", "code_info": "1) UDI-DI:\nProduct Code: AHCV18A, Lots 980221 (exp. 01/20/2023) and 974221 (exp. 01/25/2023)\n\n2) UDI-DI:\nProduct Code: AHCV18B, Lots 868221 (exp. 05/31/2023), 842221 (exp. 05/31/2023)", "firm_fei_number": "3008908305", "recalling_firm": "American Contract Systems, Inc.", "address_1": "4801 W 81st St", "city": "Bloomington", "state": "MN", "postal_code": "55437-1111", "additional_info_contact": "Angela Bunn\n470-364-7147", "reason_for_recall": "Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.", "root_cause_description": "No Marketing Application", "action": "A customer letter dated 08/12/2022 was sent on or around 08/15/2022 to the single impacted consignee. The customer is instructed that the product cannot be used in association with SARS-CoV-2 or COVID-19 testing but instead only for general use of specimen collection. The product is to be relabeled in accordance with the recall communication letter. A Field Action Response Form is to be completed and returned to angela.bunn@owens-minor.com.\n\nA second customer letter dated September 8, 2022 was sent on or around the same day to notify the consignee that 2 lots listed in this event cannot be relabeled, as they are subject to destruction from a previous recall event. Those two lots are Product #AHCV18A, lots 980221 and 974221. The consignee is requested to confirm destruction of the lots.", "product_quantity": "39,575 kits", "distribution_pattern": "Distribution to one customer in PA only", "openfda": { "k_number": [ "K791543", "K142366", "K141506", "K242576", "K242976", "K211256", "K032246", "K042970", "K792712", "K881539", "K800832", "K150887", "K863527", "K180052", "K872213", "K162284", "K860657", "K965149", "K220908", "K943498", "K844369", "K931922", "K972726", "K955451", "K910180", "K871404", "K946283", "K885244", "K113249", "K935987", "K834125", "K231027", "K961046", "K160082", "K864237", "K212856", "K941579", "K831159", "K232357", "K946286", "K962843", "K935618", "K946284", "K932337", "K240235", "K791545", "K791514", "K921472", "K854715", "K965151", "K936078", "K864998", "K231843", "K946288", "K964637", "K834316", "K212743", "K834315", "K163436", "K861080", "K211707", "K024240", "K965150", "K850717", "K791515", "K860178", "K885245", "K970597", "K863164", "K965152", "K872507", "K863602", "K024237", "K946287", "K881105", "K844747", "K844370", "K881529", "K220739", "K220052", "K854061", "K233449", "K871065", "K910526", "K202531", "K881569", "K854986", "K946285", "K914894", "K250205", "K841205", "K142094", "K913789", "K232565", "K860656", "K850124", "K860658", "K233534", "K001780", "K853500", "K201674", "K822886", "K823179", "K230035", "K863682", "K844634", "K993812", "K232454", "K943499", "K831059", "K802303" ], "device_name": "Culture Media, Non-Propagating Transport", "medical_specialty_description": "Microbiology", "regulation_number": "866.2390", "device_class": "1", "registration_number": [ "3027519599", "9617475", "3013188547", "3014150341", "1216735", "3009547954", "1917413", "1318354", "3018348", "3012494290", "1924669", "1720929", "3017063217", "9610649", "3024463179", "3036773433", "3035375122", "3001124136", "3005739529", "3013245669", "3006198300", "1417592", "3016837106", "3005182159", "2243072", "9681465", "3011689956", "1063851", "3010600155", "3002444944", "2436875", "3016741564", "3010132111", "3009613136", "3014588186", "1043646", "3009963993", "2013736", "3000268902", "9681576", "2183744", "8020040", "1319639", "1524213", "3003750284", "9613662", "3011649813", "3015505238", "3016838963", "2022807", "1220477", "3010407203", "3013661582", "3017830316", "9680143", "3009732568", "3012389632", "3015441043", "3015173212", "3010420046", "3013557562", "3015376545", "3014662855", "3004122598", "3012073813", "3004530258", "3043127647", "8020315", "3017231634", "3003207991", "3018779125", "3016587486", "3008132411" ], "fei_number": [ "3027519599", "1000138054", "3013188547", "3002807578", "3014150341", "1216735", "3009547954", "1917413", "1318354", "3018348", "3012494290", "1924669", "1720929", "3017063217", "3024463179", "3002808075", "3036773433", "3002807308", "3035375122", "3001124136", "3005739529", "3013245669", "3006198300", "5804", "1417592", "3000974732", "1000521444", "3016837106", "3005182159", "2243072", "3011689956", "3010600155", "3002546385", "3002444944", "3016741564", "3010132111", "3009613136", "3014588186", "3002919051", "1043646", "3009963993", "2013736", "3000268902", "2183744", "1524213", "3003750284", "3011649813", "3002807113", "3015505238", "3016838963", "2022807", "1220477", "3010407203", "3013661582", "3017830316", "3009732568", "3012389632", "3015441043", "3015173212", "3010420046", "3013557562", "3015376545", "3014662855", "3004122598", "3012073813", "3004530258", "1000442352", "3043127647", "3017231634", "3003207991", "3018779125", "3016587486", "3008132411" ] } } ] }