{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "184497", "product_res_number": "Z-0635-2021", "event_date_initiated": "2020-11-09", "event_date_created": "2020-12-17", "recall_status": "Open, Classified", "res_event_number": "86774", "product_code": "JPA", "k_numbers": [ "K013078", "K061014" ], "product_description": "K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.", "code_info": "Catalog Number: K-ACT Lot Number: 1-19-K-ACT and 2-19-K-ACT", "firm_fei_number": "1618982", "recalling_firm": "Helena Laboratories, Corp.", "address_1": "1530 Lindbergh Dr", "city": "Beaumont", "state": "TX", "postal_code": "77707-4131", "additional_info_contact": "Dr. Jessica Jones Hanka\n409-842-3714 Ext. 1177", "reason_for_recall": "Due to complaints received associated with cracked/split test tube caps.", "root_cause_description": "Nonconforming Material/Component", "action": "On 11/09/2020, international distributors were initially contacted and provided with a notification for distributors letter. On 11/16/2020 domestic customers were contacted via telephone and then a formal notification was delivered. The Recalling Firm was informing its customers to the potential of defect associated with the (flip-top) caps for some test tubes where the cap my split resulting in leaking of biohazardous fluids as users are instructed to shake the tube for proper mixing. Customers are instructed to immediately examine their inventory and quarantine affected product. If customers have further distributed the affected product, they are asked to identify the users within their facility to notify them at once of this product recall. Customers are also asked to complete and return the response form as soon as possible.\n\nFor any questions, customer can email or call the Recalling Firm as jhanka@Helena.com or 1-800-231-5663 extension 1177.", "product_quantity": "Lot 1-19-K-ACT = 314 tubes and Lot 2-19-K-ACT = 297 tubes", "distribution_pattern": "Worldwide distribution - U.S. Nationwide including in the states of NJ, NY, PA and TX. The countries of Austria, Canada, England, France, Italy, Portugal, Russia, Spain.", "openfda": { "k_number": [ "K983892", "K924393", "K023141", "K790204", "K883689", "K934747", "K964946", "K884534", "K160502", "K050053", "K875089", "K853789", "K082675", "K960875", "K761172", "K926551", "K002080", "K201440", "K001067", "K853077", "K972260", "K853986", "K862537", "K253658", "K183160", "K992959", "K232018", "K900506", "K951891", "K093167", "K791586", "K812124", "K833272", "K083842", "K885076", "K233790", "K981815", "K173202", "K974799", "K940957", "K883484", "K061014", "K981711", "K955724", "K013114", "K050243", "K893650", "K021162", "K151259", "K854376", "K854938", "K093001", "K050016", "K870831", "K812121", "K954202", "K882444", "K202101", "K930849", "K850409", "K051030", "K870687", "K923761", "K083896", "K030818", "K150678", "K250965", "K082248", "K011235", "K193041", "K860719", "K162688", "K101533", "K161312", "K790323", "K761173", "K870960", "K955720", "K812122", "K900377", "K931149", "K870771", "K002177", "K183390", "K221359", "K900917", "K914188", "K942096", "K760594", "K853076", "K980839", "K851153", "K990449", "K060162", "K872377", "K251024", "K930068", "K842717", "K841523", "K000973", "K002400", "K864271", "K864532", "K924124", "K852450", "K071265", "K894466", "K924509", "K151867", "K853328", "K761176", "K951497", "K000053", "K761175", "K983460", "K050513", "K162420", "K150041", "K933886", "K853198", "K894359", "K883640", "K952560", "K870686", "K854089", "K792310", "K942097", "K761171", "K083175", "K870688", "K011665", "K170314", "K001064", "K853246", "K970431", "K994349", "K883637", "K984501", "K974569", "K902458", "K870685", "K010494", "K925340", "K993678", "K172286", "K864534", "K841462", "K033137", "K780810", "K083518", "K880713", "K912087", "K040359", "K933188", "K243858", "K854090", "K860342", "K853078", "K832225", "K161317", "K083159", "K172333", "K212183", "K020798", "K990566", "K854546", "K940840", "K955735", "K924453", "K883635", "K926222", "K952625", "K770606", "K851127", "K940401", "K761091", "K881367", "K130090", "K912061", "K930454", "K961908" ], "registration_number": [ "3007507465", "1219343", "3007701696", "9613959", "3004035727", "2245451", "3019849102", "1220649", "2432235", "1618982", "3010421384", "3010653929", "3007719797", "3010960914", "9610746", "3003943960", "9610806", "3012348571", "3008386529", "3009711478", "3002721930", "3020704087", "1217183", "1000340866", "8043723", "1719400", "2132111", "3015222335", "8020030", "2184009", "3006198300", "2431530", "3037000637", "3005792925", "1644474", "2026994", "1219738", "1718389", "3005269352", "3003601075" ], "fei_number": [ "3007507465", "1219343", "3007701696", "3002808301", "3004035727", "2245451", "3006461677", "3019849102", "1220649", "2432235", "1618982", "3010421384", "2250033", "3010653929", "1000116158", "3007719797", "3010960914", "3003943960", "3002806557", "3012348571", "3001644026", "3008386529", "3009711478", "1000140026", "3020704087", "1217183", "1000340866", "1000116989", "1719400", "3001573851", "3015222335", "3006198300", "2431530", "3037000637", "3005792925", "2026994", "1219738", "1718389", "3005269352", "3003601075" ], "device_name": "System, Multipurpose For In Vitro Coagulation Studies", "medical_specialty_description": "Hematology", "regulation_number": "864.5425", "device_class": "2" } } ] }