{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "112532", "product_res_number": "Z-0193-2013", "event_date_initiated": "2010-08-04", "event_date_posted": "2012-11-05", "recall_status": "Terminated", "event_date_terminated": "2014-08-14", "res_event_number": "63094", "product_code": "JPK", "k_numbers": [ "K024173" ], "product_description": "Boule Con Diff US Tri Pack, 6 Vials.\n\nFor in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.", "code_info": "Product part 501-605, Lot #1005-549", "firm_fei_number": "3002684533", "recalling_firm": "Clinical Diagnostic Solutions", "address_1": "1800 Nw 65th Ave Ste 2 1800 Nw 65th Ave", "address_2": "Ste 2", "city": "Plantation", "state": "FL", "postal_code": "33313-4544", "additional_info_contact": "Maritza Pastoriza\n954-791-1773", "reason_for_recall": "Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule", "root_cause_description": "Process control", "action": "Clinical Diagnostic Solutions, Inc. sent a \"PRODUCT NOTIFICATION:BOULE CON DIFF TRI-LEVEL LOT 1005-549\" letter dated August 4, 2010 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions regarding this notice, contact CDS Customer Service at 1-800-453-3328.", "product_quantity": "532 packs", "distribution_pattern": "Nationwide Distribution.", "openfda": { "k_number": [ "K120744", "K770386", "K781573", "K771753", "K960005", "K912133", "K904464", "K810756", "K923971", "K120742", "K802265", "K160590", "K792055", "K952720", "K042336", "K960471", "K760549", "K801054", "K852372", "K060464", "K042836", "K900017", "K970331", "K812280", "K042587", "K844897", "K850250", "K914099", "K010409", "K830864", "K061320", "K841809", "K042094", "K081641", "K792606", "K842286", "K843962", "K760162", "K100790", "K984099", "K843805", "K952245", "K160586", "K905524", "K941965", "K791228", "K024173", "K955016", "K141957", "K935196", "K780714", "K160588", "K833563", "K013898", "K850755", "K820731", "K942822", "K010470", "K802143", "K051339", "K801265", "K972170", "K010461", "K792467", "K812237", "K020229", "K160606", "K072096", "K834371", "K873354", "K780980", "K943335", "K801267", "K820400", "K760682", "K021922", "K141964", "K800938", "K780835", "K791226", "K993496", "K003874", "K790525", "K063218", "K851663", "K130962", "K972172", "K841531", "K803084", "K781247", "K935343", "K791227", "K010066", "K802141", "K013842", "K940181", "K070199", "K072846", "K770095", "K984216", "K061511", "K791750", "K791030", "K983032", "K081822", "K840302", "K091303", "K781786", "K863224", "K780140", "K954137", "K851375", "K944751", "K803073", "K843485", "K904461", "K790415", "K991876", "K781572", "K833130", "K010064", "K100050", "K844928", "K913879", "K860751", "K844927", "K760597", "K854353", "K770384", "K890749", "K772195", "K930119", "K871067", "K884266", "K061064", "K000115", "K050721", "K073178", "K100607", "K943336", "K853776", "K831704", "K072268", "K971469", "K770020", "K003534", "K101578", "K862186", "K091433", "K760596", "K791772", "K002511", "K893895", "K041457", "K842440", "K790457", "K781969", "K022968", "K880270", "K790826", "K904637", "K820401", "K843093", "K931947", "K862318", "K955334", "K010598", "K781745", "K090201", "K003208", "K802267", "K831094", "K082162", "K051706", "K800780", "K841239", "K940089", "K053362", "K960557", "K011410", "K803083", "K802142", "K961673", "K834043", "K842109", "K800361", "K852992", "K812357", "K890767", "K781077", "K792209", "K842017" ], "registration_number": [ "1616487", "3009711478", "3013660430", "3017448032", "3008311438", "3008352382", "2221819", "1950302", "1219029", "3027394506", "1064130", "2249801", "3003741796", "2182501", "1827821", "3000148879", "3010127294", "2016706", "3023162659", "1220649", "1938095", "1064608", "1217058", "9613959", "3005333358", "3014150341", "1061932", "1017835", "3007603826", "2432235", "2020715", "3010939897" ], "fei_number": [ "1616487", "3009711478", "3003238169", "3013660430", "3017448032", "3008311438", "3008352382", "2221819", "1950302", "1219029", "3000203293", "3027394506", "3002684533", "3002808301", "3003741796", "2182501", "1827821", "3000148879", "3010127294", "2016706", "3023162659", "1220649", "1938095", "3003071743", "1217058", "3005333358", "3014150341", "1017835", "3007603826", "2432235", "2020715", "3010939897" ], "device_name": "Mixture, Hematology Quality Control", "medical_specialty_description": "Hematology", "regulation_number": "864.8625", "device_class": "2" } } ] }