{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "199406", "product_res_number": "Z-1575-2023", "event_date_initiated": "2023-03-22", "event_date_posted": "2023-05-10", "recall_status": "Open, Classified", "res_event_number": "92007", "product_code": "JPA", "k_numbers": [ "K151867" ], "product_description": "STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026", "code_info": "UDI-DI: 036074505901;\nSerial Numbers: CP86010393\nDB68093186\nCP87010814\nCP86070669\nCP86090743\nCP86090744", "firm_fei_number": "2245451", "recalling_firm": "Diagnostica Stago, Inc.", "address_1": "5 Century Dr", "city": "Parsippany", "state": "NJ", "postal_code": "07054-4607", "reason_for_recall": "An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).", "root_cause_description": "Device Design", "action": "Customers were contacted via telephone and an URGENT: MEDICAL DEVICE CORRECTION notification letter beginning 3/22/23.\n\nActions:\nStago downgraded your firmware to the previous firmware version as a precaution. Your downgrade has already occurred. Consequently, the risk of this bug only existed during the time period shown above (i.e. from new firmware installation date to the downgrade date). \n\nAs patient results are interpreted in association with other biological tests, we leave the decision to review previous patient results based on the complete clinical context to your discretion. Our Customer Service team is available to help you carry out your impact analysis.\n\nFor additional information, please contact your Stago Hotline at 1-800-725-0607.", "product_quantity": "6 analyzers", "distribution_pattern": "US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.", "openfda": { "k_number": [ "K924393", "K002080", "K842717", "K853078", "K970431", "K862537", "K050016", "K984501", "K010494", "K872377", "K000053", "K894359", "K974799", "K883635", "K974569", "K083896", "K853789", "K864532", "K000973", "K983892", "K033137", "K994349", "K150041", "K050513", "K893650", "K050243", "K212183", "K853198", "K940957", "K183160", "K992959", "K924509", "K253658", "K161312", "K990566", "K980839", "K853076", "K854546", "K925340", "K833272", "K900506", "K870687", "K832225", "K990449", "K933886", "K926551", "K885076", "K900377", "K770606", "K001064", "K790323", "K021162", "K993678", "K233790", "K250965", "K961908", "K880713", "K761175", "K093001", "K760594", "K150678", "K954202", "K884534", "K251024", "K924124", "K761176", "K981815", "K931149", "K761171", "K761091", "K151259", "K013114", "K082675", "K883689", "K790204", "K172333", "K201440", "K161317", "K902458", "K940401", "K881367", "K912087", "K926222", "K761173", "K183390", "K001067", "K960875", "K051030", "K193041", "K792310", "K002177", "K854376", "K883484", "K983460", "K812124", "K875089", "K853077", "K002400", "K761172", "K923761", "K061014", "K130090", "K930454", "K093167", "K870960", "K955735", "K780810", "K011665", "K930068", "K083518", "K854938", "K023141", "K900917", "K981711", "K243858", "K951891", "K172286", "K955724", "K173202", "K951497", "K040359", "K791586", "K083842", "K864534", "K870771", "K955720", "K860719", "K030818", "K851127", "K912061", "K864271", "K083159", "K170314", "K812121", "K852450", "K853986", "K854089", "K952560", "K972260", "K841462", "K952625", "K162420", "K020798", "K942097", "K083175", "K151867", "K162688", "K914188", "K851153", "K933188", "K853328", "K870831", "K202101", "K841523", "K894466", "K232018", "K870685", "K101533", "K930849", "K924453", "K854090", "K883640", "K860342", "K882444", "K942096", "K850409", "K050053", "K853246", "K870688", "K071265", "K870686", "K883637", "K964946", "K221359", "K060162", "K812122", "K011235", "K160502", "K940840", "K934747", "K082248" ], "registration_number": [ "3005792925", "3015222335", "3012348571", "1719400", "3037000637", "1217183", "3003943960", "3002721930", "1220649", "3003601075", "3010653929", "3009711478", "8020030", "3010960914", "1644474", "1219738", "3007701696", "3019849102", "3007719797", "2245451", "1618982", "2184009", "2432235", "1219343", "2431530", "3004035727", "9610806", "2132111", "1718389", "3005269352", "3008386529", "3020704087", "9613959", "1000340866", "8043723", "3006198300", "2026994", "3010421384", "3007507465", "9610746" ], "fei_number": [ "2250033", "3005792925", "1000140026", "3015222335", "3012348571", "3001573851", "1719400", "3037000637", "1217183", "3003943960", "3001644026", "3006461677", "1220649", "3003601075", "3010653929", "3009711478", "3010960914", "3002806557", "1219738", "3007701696", "3019849102", "2245451", "3007719797", "1618982", "1000116158", "2432235", "1219343", "2431530", "3004035727", "3002808301", "1718389", "3005269352", "3008386529", "3020704087", "1000116989", "1000340866", "3006198300", "2026994", "3010421384", "3007507465" ], "device_name": "System, Multipurpose For In Vitro Coagulation Studies", "medical_specialty_description": "Hematology", "regulation_number": "864.5425", "device_class": "2" } } ] }