{ "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": "190646", "product_res_number": "Z-0554-2022", "event_date_initiated": "2021-12-01", "event_date_created": "2022-02-02", "recall_status": "Terminated", "event_date_terminated": "2023-01-09", "res_event_number": "89151", "product_code": "JTO", "k_numbers": [ "K960996" ], "product_description": "HARDY DIAGNOSTICS CatScreen, 25dsk/vial", "code_info": "Model Number HADZ110, all lots", "firm_fei_number": "1417592", "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "additional_info_contact": "Karin Johnson\n866-359-1704", "reason_for_recall": "Product stored incorrectly in temperature controlled setting instead of refrigeration.", "root_cause_description": "Process control", "action": "Medline notified consignees on 12/01/2021, via first class mail letter titled URGENT RECALL NOTIFICATION. Customers were instructed to immediately check stock for affected product, quarantine any affected product on hand, complete and return the response form indicating product destroyed, and notify customers if the product was further distributed.", "product_quantity": "100 units (4 packs, 25 per pack)", "distribution_pattern": "US Nationwide distribution in the state of California.", "openfda": { "k_number": [ "K970833", "K841262", "K930717", "K830968", "K940161", "K840252", "K882636", "K830099", "K912480", "K820213", "K844380", "K970834", "K831187", "K801916", "K823718", "K820209", "K832306", "K830323", "K840819", "K820204", "K864244", "K960996", "K842587", "K840030", "K840708", "K842086", "K802501", "K862570", "K832436", "K821992", "K841508", "K802496", "K781567", "K802500", "K860562", "K844383", "K844086", "K874933", "K834022", "K931414", "K812458", "K913007", "K905666", "K970832", "K890625", "K934129", "K801915", "K811998", "K930718", "K873034", "K913008", "K934130", "K921583", "K913006", "K913011", "K811853", "K802509", "K945882", "K831674", "K842828", "K934986", "K812859", "K841453", "K870449", "K863216", "K931862", "K902037", "K880950", "K951889", "K802566", "K823738", "K844887", "K905472", "K820211", "K860156", "K800816", "K812047", "K894221", "K945883", "K844382", "K896398", "K840804", "K923827", "K802127", "K930878", "K954783", "K841270", "K931413", "K801493", "K822930", "K840884", "K830939", "K770926", "K852832", "K840580", "K860091", "K905151", "K812862", "K834389", "K831673", "K941111", "K863601", "K936034", "K920972", "K813509", "K901784", "K880694", "K860565", "K790038", "K940124", "K812084", "K830756", "K833407", "K833654", "K854448", "K901390", "K861058", "K844019", "K832305", "K860563", "K840582", "K844020", "K860564", "K920257", "K801492", "K970009", "K813613", "K823198", "K870717", "K840031", "K840028", "K822946", "K870410", "K902595", "K931865", "K873509", "K813610", "K812877", "K870561", "K945880", "K820205", "K843521", "K840584", "K840583", "K852886", "K820207", "K801951", "K930720", "K925747", "K913001", "K962966", "K840581", "K923700", "K050352", "K920971", "K761209", "K860396", "K913004", "K840578", "K840810", "K851184", "K934125", "K834581", "K871445", "K843316", "K840686", "K950346", "K811854", "K913003", "K800579", "K926254", "K840508", "K832307", "K941016", "K844276", "K813031", "K852889", "K953247", "K913009", "K821040", "K945881", "K920973", "K840896", "K802497", "K841329", "K841277", "K810541", "K833963", "K834029", "K870409", "K902640", "K933514", "K843987", "K955826", "K834269", "K831654", "K926256", "K840029", "K782086", "K860302", "K812082", "K926255", "K820210", "K820212", "K882630", "K841479", "K832587", "K852666", "K961191", "K813442", "K871907", "K840579", "K840577", "K861259", "K840575", "K802502", "K860560", "K820264", "K940162", "K860301", "K840483", "K930693", "K833901", "K940020", "K905163", "K840576", "K870422", "K821907", "K861889", "K932752", "K840614", "K913002", "K841460", "K860561", "K834028", "K813612", "K954812", "K812083", "K820206", "K936021", "K913010", "K844381", "K861888", "K870716" ], "registration_number": [ "3013490757", "1924669", "2247035", "3043126851", "8010383", "1210083", "2647876", "8010096", "2022807", "3024171133", "9615754", "3013160357", "3009171251", "3016741564", "3006091463", "1119779", "9610649", "9615755", "2242239", "3003750284", "8020667", "3009307598", "3006440892", "2016672", "3006897996", "3023191945", "2916932" ], "fei_number": [ "1000122268", "3013490757", "1924669", "4247", "3043126851", "1210083", "2647876", "1000220444", "2022807", "3008237827", "3024171133", "3002807578", "3013160357", "1000354384", "3016741564", "3006091463", "3006224287", "1119779", "2242239", "3003750284", "3007808629", "3009307598", "3006440892", "3006897996", "3006759904", "3023191945", "2916932" ], "device_name": "Discs, Strips And Reagents, Microorganism Differentiation", "medical_specialty_description": "Microbiology", "regulation_number": "866.2660", "device_class": "1" } } ] }