{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "70970", "product_res_number": "Z-0516-2009", "event_date_initiated": "2007-06-01", "event_date_posted": "2009-01-17", "recall_status": "Terminated", "event_date_terminated": "2009-02-18", "res_event_number": "48190", "product_code": "JPK", "k_numbers": [ "K010598" ], "product_description": "Quantimetrix Synovialscopics Synovial Fluid Control.\n\nSynovialscopics is a plastic bottle Synovial fluid cell count control. It is a control for monitoring total cell counts in patient Synovial fluid samples performed manually using a hemocytometer. It is also an aid for identifying the crystals which may indicate a pathological condition present in the Synovial fluid. This control is used as a third party control to confirm proper functioning of the analysis by microscopic evaluation.", "code_info": "Lot Numbers: 38050 and 38060.", "firm_fei_number": "2020715", "recalling_firm": "Quantimetrix Corporation", "address_1": "2005 Manhattan Beach Blvd", "city": "Redondo Beach", "state": "CA", "postal_code": "90278-1205", "additional_info_contact": "310-536-0006", "reason_for_recall": "This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.", "root_cause_description": "Employee error", "action": "The recall communication was initiated when customer both direct and distributors who have purchased the lots were mailed a recall notification letter dated June 8, 2008 with instructions which was sent via first class mail.\n\nCustomers were requested to assist in the voluntary recall of the listed product and if any of the affected lots have been consumed please review their records to ensure that the obtained values conform to the stated specifications found in the lot specific product insert.", "product_quantity": "24,937 sets for all products.", "distribution_pattern": "Nationwide Distribution including states of AK, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, NC, ND, NH, NM, NY, OR, PA, SC, SD, TN, TX, VA, WA and WY.", "openfda": { "k_number": [ "K812280", "K780714", "K091303", "K781786", "K844928", "K862186", "K952245", "K790826", "K941965", "K800938", "K935196", "K792606", "K972170", "K802142", "K972172", "K792209", "K871067", "K081641", "K791750", "K812357", "K904464", "K003534", "K803084", "K141957", "K024173", "K803073", "K930119", "K943336", "K802267", "K781745", "K061511", "K834371", "K760596", "K840302", "K890749", "K940089", "K041457", "K042094", "K010461", "K820401", "K053362", "K931947", "K942822", "K873354", "K842440", "K802141", "K120744", "K842109", "K991876", "K984216", "K770095", "K843962", "K852372", "K841239", "K781572", "K800361", "K063218", "K021922", "K780835", "K905524", "K983032", "K831704", "K851375", "K884266", "K792467", "K970331", "K010409", "K792055", "K020229", "K051339", "K984099", "K935343", "K841531", "K844897", "K842286", "K770020", "K812237", "K101578", "K944751", "K061320", "K791772", "K960557", "K852992", "K780140", "K160606", "K940181", "K955016", "K914099", "K863224", "K130962", "K900017", "K820400", "K904637", "K771753", "K160586", "K070199", "K010470", "K862318", "K890767", "K060464", "K954137", "K790525", "K072096", "K904461", "K011410", "K073178", "K003208", "K843093", "K081822", "K781573", "K850250", "K820731", "K801267", "K960005", "K971469", "K100790", "K010064", "K051706", "K912133", "K841809", "K790415", "K091433", "K843805", "K781969", "K955334", "K100050", "K830864", "K833563", "K013898", "K851663", "K880270", "K003874", "K860751", "K000115", "K913879", "K160590", "K791226", "K833130", "K760549", "K022968", "K013842", "K061064", "K770386", "K961673", "K160588", "K993496", "K090201", "K100607", "K082162", "K831094", "K791227", "K072268", "K923971", "K072846", "K050721", "K791228", "K781247", "K800780", "K893895", "K770384", "K834043", "K042836", "K791030", "K844927", "K760162", "K810756", "K854353", "K120742", "K772195", "K010598", "K802265", "K960471", "K760597", "K801054", "K803083", "K801265", "K952720", "K760682", "K002511", "K010066", "K781077", "K802143", "K850755", "K943335", "K042587", "K853776", "K141964", "K042336", "K790457", "K842017", "K843485", "K780980" ], "device_name": "Mixture, Hematology Quality Control", "medical_specialty_description": "Hematology", "regulation_number": "864.8625", "device_class": "2", "registration_number": [ "3027394506", "2432235", "3010127294", "1219029", "3017448032", "2221819", "3014150341", "1064130", "3010939897", "9613959", "3013660430", "1827821", "2249801", "1616487", "3003741796", "3023162659", "1061932", "1938095", "1064608", "1950302", "3008311438", "1017835", "3009711478", "2020715", "1217058", "3007603826", "3000148879", "3005333358", "2182501", "1220649", "2016706", "3008352382" ], "fei_number": [ "3027394506", "2432235", "3010127294", "1219029", "3017448032", "2221819", "3014150341", "3000203293", "3010939897", "3013660430", "1827821", "3002684533", "3003071743", "1616487", "3003238169", "3003741796", "3023162659", "1938095", "1950302", "3008311438", "1017835", "3009711478", "2020715", "1217058", "3007603826", "3000148879", "3005333358", "2182501", "1220649", "2016706", "3002808301", "3008352382" ] } } ] }