{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "94324", "product_res_number": "Z-0139-2011", "event_date_initiated": "2010-08-19", "event_date_posted": "2010-10-25", "recall_status": "Terminated", "event_date_terminated": "2010-10-26", "res_event_number": "56703", "product_code": "CEM", "k_numbers": [ "K051087" ], "product_description": "Dimension Vista V-LYTE Standard A, Catalog No K820\nFor the calibration of Na+/K+/Cl- on the Dimension vista System.", "code_info": "KA0C03 EXP 3/24/11, KA0D01 EXP 4/14/11, KA0E01 EXP 5/5/11, KA0E02 EXP 5/19/11, KA0F01 EXP 6/3/11, AND KA0G01 EXP 7/8/11", "firm_fei_number": "2517506", "recalling_firm": "Siemens Healthcare Diagnostics, Inc.", "address_1": "500 GBC Drive, Mailstop 514 500 GBC Drive Mailstop 514", "address_2": "PO BOX 6101", "city": "Newark", "state": "DE", "postal_code": "19714-6101", "additional_info_contact": "Aydee Crawford\n302-631-6311", "reason_for_recall": "High potassium content in the affected lots results in the potential for low potassium recovery for Dilution Check, QC and patient samples when run on the Dimension Vista System.", "root_cause_description": "Other", "action": "Siemens sent an Urgent Field Safety Notice (dated \"August 2010\") to customers identifying the product, the problem and the action to be taken. Customers were instructed on how to continue testing until new lots of the recalled product were available and asked to complete and fax a Field Correction Effectiveness Check to 301-631-8467 to confirm receipt of the Urgent Field Safety Notice. For technical questions or concerns customers were instructed to contact the Siemens Technical Solutions Center at 800-441-9250.", "product_quantity": "3,706 cartons", "distribution_pattern": "USA, Nationwide Distribution", "openfda": { "k_number": [ "K811310", "K061107", "K061730", "K851808", "K832036", "K993083", "K083680", "K851100", "K112412", "K961115", "K843454", "K010061", "K842786", "K897110", "K800054", "K840887", "K843239", "K853356", "K974784", "K840961", "K800016", "K042291", "K844044", "K093318", "K073157", "K843008", "K220396", "K112408", "K121012", "K923038", "K110520", "K901039", "K884769", "K112995", "K791175", "K915177", "K821822", "K890792", "K896692", "K771118", "K253491", "K833696", "K092686", "K844806", "K791692", "K970330", "K854723", "K883240", "K241037", "K830104", "K915178", "K895664", "K802158", "K121040", "K052914", "K040750", "K851350", "K932044", "K853531", "K900300", "K915345", "K822441", "K042270", "K060373", "K771837", "K850950", "K842315", "K884566", "K854298", "K961326", "K870657", "K833159", "K853068", "K870033", "K833776", "K032311", "K112788", "K013373", "K900788", "K092849", "K922943", "K844955", "K901041", "K200544", "K790018", "K230890", "K800692", "K912649", "K841575" ], "registration_number": [ "", "3003795116", "1827821", "3004102403", "1000414342", "3002809144", "2432235", "1717966", "3009473156", "9610126", "3003637681", "3010324880", "3000308930", "3003030793", "1000256526", "3006198300", "2030861", "3002637618", "3005643513", "2431530", "3004959793", "1000455123", "2050012", "2221819", "1222035", "8020888", "3005509212", "2250051", "9614698", "3008244372", "3007662974", "3007490412", "1616487", "2085064", "3012817228", "1220972", "1036362", "3003593973", "9610633", "1319809", "1217183", "3007603826", "3014607865", "3016438761", "9610816", "3003971136", "3016244760", "3012963943", "3037000637", "3002642396", "3005333358", "3023268435", "9680746", "3004493545", "3002807968", "1317202", "3004378326", "3013513377", "9610529", "2245578", "3014506106", "3010825766", "3023162659", "1219029", "1036223", "2050010", "1220649", "2247288", "1181121", "9614673", "3011989923", "1219913", "1319681", "3009156722", "8030478", "8020316", "9612296", "3004438098", "2939693", "1319436", "3000148879", "2517506", "3000126629" ], "fei_number": [ "", "3003795116", "1827821", "1000122044", "3004102403", "1000414342", "3002809144", "2432235", "1717966", "3009473156", "3003637681", "3010324880", "3000308930", "3003030793", "1000256526", "3006198300", "3002637618", "3005643513", "3003559576", "2431530", "3004959793", "3002807167", "3007019572", "3002807663", "3002806809", "1000455123", "2050012", "1000206808", "2221819", "1222035", "3005509212", "2250051", "3008244372", "3007662974", "3007490412", "1616487", "3012817228", "1220972", "1036362", "3003593973", "1217183", "3007603826", "3002808382", "3014607865", "3016438761", "3003971136", "3016244760", "3012963943", "3037000637", "3002642396", "3005333358", "1000120319", "1000305840", "3023268435", "3002806560", "3000215862", "3004493545", "3002807968", "1000136573", "1317202", "3004378326", "3001576181", "3002806559", "1000135102", "3013513377", "2245578", "3014506106", "3010825766", "3023162659", "1219029", "1036223", "2050010", "1220649", "1181121", "3011989923", "1219913", "3009156722", "3004438098", "2939693", "3002806693", "3000148879", "2517506", "3000126629" ], "device_name": "Electrode, Ion Specific, Potassium", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1600", "device_class": "2" } } ] }