{ "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": 2 } }, "results": [ { "cfres_id": "214647", "product_res_number": "Z-2237-2025", "event_date_initiated": "2025-07-08", "event_date_posted": "2025-08-01", "recall_status": "Open, Classified", "res_event_number": "97141", "product_code": "GKZ", "product_description": "BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD", "code_info": "Lot: 4285713/UDI: 00382906643438", "firm_fei_number": "3027394506", "recalling_firm": "Becton, Dickinson and Company, BD Bio Sciences", "address_1": "155 N Mccarthy Blvd", "city": "Milpitas", "state": "CA", "postal_code": "95035-5102", "additional_info_contact": "BD Customer Service\n1844-823-5433", "reason_for_recall": "Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.", "root_cause_description": "Labeling design", "action": "On July 8, 2025, BD Biosciences issued a \"Urgent: Medical Device Recall Correction\" via mail. BD ask consignees to take the following actions:\n\n1.\tEnsure the contents of this product notification are read and understood.\n\n2.\tShare and post this customer letter with the users of this application at your facility and forward to any customers to whom you may have distributed the product to ensure awareness.\n\n3.\tIt is recommended that this notice be posted where these products are stored.\n\n4.\tComplete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted product, so that BD may acknowledge your receipt of this notification.\n\n5.\tReport any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program.", "product_quantity": "10 kits", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of Tennessee, New York, Massachusetts and the countries of Argentina, Belgium, Botswana, Brazil, Canada, France, Germany, Lithuania, Peru, Philippines, United Kingdom.", "openfda": { "k_number": [ "K883177", "K961623", "K864579", "K083420", "K220031", "K900593", "K855116", "K854368", "K871600", "K030828", "K900802", "K032342", "K943967", "K853304", "K190898", "K960887", "K932030", "K923237", "K950919", "K061616", "K910473", "K071143", "K170353", "K894179", "K051215", "K953116", "K050057", "K954188", "K910834", "K172604", "K002646", "K840195", "K875047", "K884020", "K021241", "K042724", "K953643", "K921567", "K884346", "K030144", "K831271", "K945205", "K770680", "K991605", "K871837", "K020496", "K964856", "K885028", "K914848", "K000611", "K964988", "K904209", "K900276", "K051199", "K890349", "K932530", "K990311", "K180020", "K933475", "K990327", "K972354", "K882612", "K933478", "K060656", "K946335", "K950918", "K911385", "K944127", "K950057", "K901188", "K901187", "K030408", "K980858", "K803219", "K012904", "K032524", "K022668", "K932531", "K960827", "K973634", "K120771", "K991539", "K953302", "K153538", "K081495", "K885093", "K053497", "K884605", "K081610", "K913259", "K944126", "K991839", "K950342", "K782050", "K895127", "K853027", "K200828", "K240402", "K883753", "K950482", "K000897", "K030263", "K770701", "K993356", "K980635", "K042173", "K012934", "K950625", "K171655", "K850354", "K003677", "K925528", "K982166", "K230878", "K915071", "K951100", "K193124", "K954594", "K936023", "K932532", "K872761", "K951496", "K951632", "K821186", "K050436", "K963954", "K111534", "K063407", "K790816", "K140911", "K951073", "K874838", "K922745", "K971205", "K921279", "K182389", "K141681", "K780577", "K965232", "K874147", "K922744", "K980614", "K022200", "K950917", "K091313", "K030513", "K882557", "K190294", "K951459", "K992444", "K240252", "K042251", "K963963", "K791041", "K954688", "K883710", "K050758", "K982167", "K053308", "K800533", "K050589", "K873256", "K904390", "K050719", "K893423", "K943284", "K032000", "K854242", "K071967", "K852371", "K791108", "K040073", "K081526", "K925255", "K143348", "K072869", "K974360", "K941713", "K901186", "K880616", "K050421", "K941171", "K892205", "K945692", "K102064", "K230887", "K102644", "K160538", "K855117", "K914846", "K900078", "K071681", "K823355", "K022161", "K940003", "K901189", "K925909", "K962768", "K991454", "K891276", "K982231", "K090810", "K040026", "K022528", "K853029", "K884006", "K922704", "K910283", "K243283", "K953340", "K913192", "K010953", "K922085", "K251371", "K992849", "K925274", "K962305", "K895917", "K950949", "K913305", "K981342", "K833618", "K081213", "K953498", "K040725", "K954570", "K991402", "K930913", "K950626", "K051122", "K060423", "K990172", "K030291", "K914014", "K896873", "K982802", "K923790", "K945212", "K950916", "K210346", "K893853", "K182886", "K952182", "K060375", "K945837", "K143577", "K093394", "K926124", "K944253", "K970326", "K961439", "K110381", "K222148", "K232946", "K944128", "K953448", "K992875", "K043215", "K942797", "K920544", "K911626", "K893852", "K062087", "K924587", "K961435", "K882579", "K960072", "K181475", "K141161", "K920949", "K052905", "K943894", "K991142", "K911793", "K981568", "K151133", "K992511", "K833600", "K933486", "K010765", "K904253", "K961701", "K945678", "K090013", "K983562", "K933878", "K923773", "K761207", "K011342", "K922181", "K791903", "K953598", "K181288", "K955909", "K970742", "K960531", "K880507", "K253212", "K041074", "K874763", "K961278", "K250943", "K211840", "K090346", "K003796", "K955715", "K950742", "K041882", "K162977", "K032013", "K961610", "K922084", "K950568", "K971152", "K990352", "K900684", "K051459", "K243348", "K982172", "K032039", "K942525", "K965053", "K930309", "K971110", "K160429", "K971736", "K874427", "K914744", "K964754", "K844910", "K890491", "K112755", "K970836", "K061150", "K251249", "K842636", "K852988", "K960427", "K112605", "K882370", "K883997", "K903665", "K030606", "K770244", "K770550", "K032214", "K100489", "K930148", "K770869", "K162414", "K963263", "K973483", "K082091", "K081890", "K955504", "K875346", "K061574", "K761208", "K081930", "K071562", "K935720", "K800121", "K844645", "K962633", "K964618", "K925344", "K870233", "K061667", "K024002", "K964974", "K873734", "K952789", "K240636", "K841852", "K090967", "K071141", "K946055", "K030799", "K945756", "K955673" ], "registration_number": [ "3007349751", "9613959", "3009189893", "2919069", "3009297077", "3003601075", "3014053517", "1000292377", "3009156722", "3005146313", "3013059683", "3006606827", "1063851", "9610099", "2914537", "3003589956", "1061932", "1832816", "3016090200", "3008352382", "3005333358", "2032112", "3020704087", "3003630693", "1221433", "3010960914", "3010421384", "3038625004", "1950302", "8020888", "3013445220", "1017835", "3011765035", "3002809144", "3006946274", "3009834076", "1064608", "3008096179", "3002759288", "2221819", "3010324880", "3004008703", "3003423869", "3009495621", "3013608230", "3000148879", "8040564", "1036362", "3027394506", "3007113174", "3009711478", "3007750372", "1181121", "3007603826", "2182501", "3006412379", "3006198300", "3016438761", "3039523350", "3008425728", "8023018", "3009092698", "2432235", "1415939" ], "fei_number": [ "3007349751", "3009189893", "3002808301", "2919069", "3009297077", "3003601075", "3014053517", "3002807272", "1000292377", "3009156722", "3005146313", "3013059683", "3006606827", "2914537", "3003589956", "1832816", "3016090200", "3008352382", "3005333358", "3020704087", "3003071743", "3003630693", "1221433", "3010960914", "3010421384", "3038625004", "1950302", "3013445220", "1017835", "3011765035", "3002809144", "3006946274", "3003076831", "6137", "3009834076", "3008096179", "3002759288", "2221819", "3010324880", "3004008703", "3003423869", "3009495621", "3002806778", "3013608230", "3000148879", "3007750372", "1036362", "3027394506", "3007113174", "3009711478", "3007019572", "1181121", "3007603826", "2182501", "3006412379", "3006198300", "3016438761", "3000203293", "3039523350", "3008425728", "3009092698", "2432235", "1000442352", "1415939" ], "device_name": "Counter, Differential Cell", "medical_specialty_description": "Hematology", "regulation_number": "864.5220", "device_class": "2" } } ] }