{ "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": 4 } }, "results": [ { "cfres_id": "215095", "product_res_number": "Z-2473-2025", "event_date_initiated": "2025-07-21", "event_date_posted": "2025-08-28", "recall_status": "Open, Classified", "res_event_number": "97287", "product_code": "JPA", "k_numbers": [ "K082248" ], "product_description": "STA Satellite. Product Code: All references. All software versions.\n\nThe STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays.", "code_info": "Product Code: All references. UDI-DI: 03607450581041, 03607450581027. All software versions.", "firm_fei_number": "2245451", "recalling_firm": "Diagnostica Stago, Inc.", "address_1": "5 Century Dr", "city": "Parsippany", "state": "NJ", "postal_code": "07054-4607", "additional_info_contact": "Technical Hotline\n800-7250607", "reason_for_recall": "Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.", "root_cause_description": "Mixed-up of materials/components", "action": "Diagnostica Stago notified consignees on about 07/21/2025 via emailed letter titled URGENT: MEDICAL DEVICE RECALL (CORRECTION). Consignees were instructed to temporarily systematically run a quality control just before a batch of UFH or LMWH, if you run STA-LIQUID ANTI-Xa in UFH and LMWH applications on your STA SATELLITE analyzer. This request is being asked while Stago works to develop a permanent solution for the analyzer. Consignees were also requested to complete and return the Acknowledgement Form and to notify customers if affected units were transferred or further distributed.", "product_quantity": "3,650 units (538 US)", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, LA, MD, ME, MN, MO, MT, NC, OH, OK, OR, PA, PR, SD, VT, WI, WY and the countries of Algeria, Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, France, French Polynesie, Guadeloupe, India, Iran, Israel, Jordan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Oman, Paraguay, Peru, Republique Tcheque, Romania, Saudi Arabia, Serbia, South Africa, Switzerland, Taiwan, Thailand, Tunisia, Turquie, United Arab Emirates, Uruguay, Vietnam.", "openfda": { "k_number": [ "K951891", "K061014", "K013114", "K050053", "K853078", "K883637", "K924124", "K853198", "K864271", "K900506", "K893650", "K854938", "K912087", "K161317", "K990566", "K980839", "K894359", "K924393", "K051030", "K854090", "K981815", "K002080", "K924509", "K183390", "K961908", "K926222", "K942096", "K854376", "K790323", "K894466", "K853077", "K970431", "K926551", "K083518", "K162688", "K870685", "K812121", "K852450", "K870687", "K172286", "K983460", "K050513", "K851127", "K790204", "K071265", "K864534", "K150678", "K161312", "K002177", "K883640", "K854089", "K940840", "K202101", "K151259", "K993678", "K883484", "K992959", "K082248", "K130090", "K001064", "K981711", "K940401", "K923761", "K853789", "K021162", "K001067", "K233790", "K974569", "K851153", "K251024", "K002400", "K151867", "K925340", "K841523", "K875089", "K960875", "K770606", "K942097", "K761173", "K954202", "K780810", "K162420", "K860719", "K955724", "K023141", "K972260", "K924453", "K011235", "K880713", "K761176", "K791586", "K964946", "K902458", "K172333", "K854546", "K083896", "K900917", "K952625", "K930849", "K170314", "K010494", "K983892", "K883635", "K864532", "K870831", "K761172", "K093167", "K243858", "K212183", "K882444", "K900377", "K000053", "K812122", "K885076", "K870686", "K860342", "K974799", "K955720", "K881367", "K030818", "K082675", "K994349", "K984501", "K832225", "K250965", "K930068", "K083842", "K853986", "K952560", "K990449", "K884534", "K101533", "K193041", "K933188", "K853246", "K183160", "K872377", "K020798", "K221359", "K173202", "K842717", "K011665", "K853076", "K760594", "K934747", "K850409", "K862537", "K093001", "K160502", "K912061", "K933886", "K050016", "K870771", "K761091", "K050243", "K853328", "K870960", "K930454", "K812124", "K833272", "K841462", "K914188", "K060162", "K955735", "K870688", "K253658", "K040359", "K951497", "K883689", "K940957", "K083159", "K201440", "K000973", "K083175", "K033137", "K761171", "K931149", "K792310", "K761175", "K150041", "K232018" ], "device_name": "System, Multipurpose For In Vitro Coagulation Studies", "medical_specialty_description": "Hematology", "regulation_number": "864.5425", "device_class": "2", "registration_number": [ "9613959", "3015222335", "3003601075", "3007701696", "1718389", "3004035727", "3003943960", "3005269352", "1217183", "2184009", "3010653929", "2431530", "9610806", "1644474", "3020704087", "3010960914", "2245451", "3010421384", "9610746", "1000340866", "3007507465", "3037000637", "8043723", "1219738", "2432235", "3007719797", "1719400", "2026994", "3005792925", "3009711478", "1219343", "3002721930", "1618982", "3019849102", "3006198300", "3012348571", "1220649", "3008386529", "8020030", "2132111" ], "fei_number": [ "3015222335", "3002808301", "3003601075", "3007701696", "2250033", "3004035727", "1718389", "3001573851", "3003943960", "3005269352", "1217183", "3010653929", "2431530", "1000116158", "3020704087", "3010960914", "2245451", "3010421384", "1000340866", "1000140026", "3007507465", "1220649", "3037000637", "1219738", "2432235", "3007719797", "1719400", "2026994", "3005792925", "3009711478", "1219343", "1618982", "1000116989", "3001644026", "3019849102", "3006198300", "3012348571", "3006461677", "3008386529", "3002806557" ] } } ] }