{ "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": "112538", "product_res_number": "Z-0191-2013", "event_date_initiated": "2011-03-24", "event_date_posted": "2012-11-02", "recall_status": "Terminated", "event_date_terminated": "2014-08-13", "res_event_number": "63096", "product_code": "JPK", "k_numbers": [ "K024173" ], "product_description": "Boule Con-Diff Hematology Control\n\nFor in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.", "code_info": "Product Part 502-012, Lot #1102-574", "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 Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complai", "root_cause_description": "Nonconforming Material/Component", "action": "Clinical Diagnostic Solutions, Inc. sent a letter dated March 24, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm istructed the accounts to replace the assay sheet they were currently using with the new assay sheets enclosed. For an unused product they would need to discard. To correct the ranges in their instrument, they would need to scan in the new bar codes specific for their instrument type. For any questions customers were instructed to contact CDE Technical Support atl 800-453-3328.\nFor questions regarding this recall call 954-791-1773.", "product_quantity": "197 vials", "distribution_pattern": "Worldwide Distribution - USA including AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, ND, ND, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI, WV,and WY. \nForeign: Brazil and Colombia", "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" } } ] }