{ "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": "129981", "product_res_number": "Z-0083-2015", "event_date_initiated": "2014-09-19", "event_date_posted": "2014-10-17", "recall_status": "Terminated", "event_date_terminated": "2015-07-20", "res_event_number": "69228", "product_code": "JIL", "k_numbers": [ "K091216" ], "product_description": "External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part\n\nThe Clinitek Status system is a urine analyzer.", "code_info": "10378632, 10378633, 10378634, 10309177, 10309178, 10324040, 10376820  Power supply adaptors embossed with the following numerical date codes: 50130, 51130, 52130, 01140, 02140, 03140, 04140, 05140, 06140, 07140, 08140, 09140, 10140, 11140, 12140, 13140, 14140, 15140, 16140, 17140, 18140, 19140, 20140, 21140, 22140, 23140", "firm_fei_number": "1219913", "recalling_firm": "Siemens Healthcare Diagnostics, Inc", "address_1": "333 Coney St", "city": "East Walpole", "state": "MA", "postal_code": "02032-1516", "additional_info_contact": "877-229-3711", "reason_for_recall": "The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.", "root_cause_description": "Process control", "action": "Siemens sent an Urgent Field Safety Notice dated September 2014, to all by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on September 19, 2014 both in the United States and elsewhere for communication with affected customers. This notice informs customers of the issue with the power supply and the potentially affected products that may contain a damaged power supply. Consignees are asked to complete a Field Correction Effectiveness Check form and return in to Siemens Healthcare Diagnostics via Fax to (312) 275-7795. \nAll affected domestic customers were sent a hard copy of the Urgent Field Safety Notice via Federal Express on 9/23/14. All affected customers outside the US will be provided a copy of an Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each countries local regulations and procedures.\nCustomers with questions were instructed to contact their local Siemens technical support representative.\nFor questions regarding this recall call 877-229-3711.", "product_quantity": "approx. 4200", "distribution_pattern": "Worldwide Distribution - USA (nationwide) including Puerto Rico and Internationally Canada, Mexico, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Latvia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed., Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, Sweden, Switzerland, Tadjikistan, Taiwan, Turkey, Turkmenistan, Unit.Arab Emir., United Kingdom, Vietnam.", "openfda": { "k_number": [ "K834386", "K181024", "K820594", "K954968", "K061742", "K131600", "K840829", "K060280", "K063390", "K864544", "K940043", "K061812", "K931897", "K932369", "K050801", "K160062", "K811818", "K770271", "K020175", "K063276", "K051034", "K771755", "K942648", "K932363", "K953661", "K895282", "K032437", "K932364", "K180356", "K932368", "K193514", "K843753", "K173327", "K843756", "K010973", "K761310", "K843758", "K141289", "K101673", "K970250", "K843757", "K841713", "K171521", "K042641", "K061846", "K834385", "K171083", "K811817", "K831498", "K033851", "K843755", "K012397", "K961375", "K120124", "K855239", "K861733", "K870500", "K952307", "K861255", "K091216", "K932365", "K896454", "K843754", "K973142", "K160372", "K932366", "K843759", "K811816", "K052525", "K991927", "K946116", "K183432", "K932367", "K843760", "K831600", "K022386", "K841714", "K952971", "K023885", "K834387", "K940469" ], "registration_number": [ "", "3012421607", "3042471840", "3008517993", "1616487", "3012494290", "2250030", "9710094", "3010324880", "3004192065", "3005841640", "9680746", "3038419886", "3011689956", "3003917514", "2531491", "3009238284", "3005360469", "3010891909", "3012118659", "3021186226", "2029372", "3007301207", "1810909", "1832816", "1649661", "3009448641", "9610633", "9610126", "3008058135", "3030446844", "1000414342", "3003741796", "3004043187", "3003422726", "3011121740", "3003795116", "9615507", "1036362", "4580", "2030633", "1061932", "3002637618", "1417592", "2432235", "1181121", "2244821", "3006198300", "2122870", "9611444", "1832216", "3006621318", "8040374" ], "fei_number": [ "", "3012421607", "3042471840", "3008517993", "3003516723", "1616487", "3005670738", "3012494290", "3010700165", "2250030", "3010324880", "3004192065", "3005841640", "3038419886", "3011689956", "5864", "3002807423", "3003917514", "3009238284", "3012118659", "3010891909", "3000203293", "3021186226", "3007301207", "1810909", "1832816", "3009448641", "3003347234", "3008058135", "3002806693", "3030446844", "1000414342", "3003741796", "3002829675", "3004043187", "3002806559", "3003422726", "3003795116", "1000306617", "1036362", "4580", "3000210620", "1000206808", "3002637618", "1417592", "2432235", "1181121", "2244821", "3001451797", "3006198300", "2122870", "1832216", "3006621318" ], "device_name": "Method, Enzymatic, Glucose (Urinary, Non-Quantitative)", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1340", "device_class": "2" } } ] }