{ "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": "150188", "product_res_number": "Z-0397-2017", "event_date_initiated": "2016-10-05", "event_date_created": "2016-11-11", "recall_status": "Terminated", "event_date_terminated": "2019-08-29", "res_event_number": "75394", "product_code": "MRG", "k_numbers": [ "K110586" ], "product_description": "Siemens ADVIA Centaur Vitamin D Total Assay\nSMN 10699201 (100 test)", "code_info": "All lot codes", "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": "SAME\n508-668-5000", "reason_for_recall": "Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples", "root_cause_description": "Device Design", "action": "Siemens issued an Urgent Medical Device Correction (UMDC) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on October 5, 2016 to be delivered to customers on October 6th, 201 6. An Urgent Field Safety Notice ~UFSN) was sent out for distribution to all customers outside the United States on October 5, 2016. These notices inform the customer of\nthe change in correlation between serum and plasma specimen tube results generated on the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT Vitamin D Total assay. \n\nA revised letter was issued on November 7, 2016 by Fedx for delivery on November 8, 2016 and advises users to: In the interim, Siemens requires that customers discontinue use of plasma tubes for specimen collection for the ADVIA Centaur Vitamin D Total assay until further notice.\n\nCustomers can continue to use the ADVIA Centaur Vitamin D Total assay with serum specimen collection tubes.\n\nAccounts to Complete and return the Field Correction Effectiveness Check Form attached within 30 days. Review the letter with your Medical Director.\nand retain this letter with your laboratory records, and forward this letter to those who may have received this product.\nQuestion contact your Siemens Customer Care Center or your local Siemens technical support representative.", "product_quantity": "69781 kits", "distribution_pattern": "Nationwide\nForeign:\nAfghanistan, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil,\nCanada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt,\nFinland, France, French Polynesia, Georgia, Germany, Great Britain, Greece, Guadeloupe,\nGuatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Italy, Japan, Jordan, Latvia, Lebanon,\nLithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Nepal, Netherlands,\nNew Zealand, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar,\nRomania, Russian Federation, Saudi Arabia, Singapore, Serbia, Slovakia, South Africa, South\nKorea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates,\nUruguay, Vietnam", "openfda": { "k_number": [ "K042519", "K180577", "K051110", "K123660", "K162754", "K210901", "K112725", "K232587", "K122420", "K172992", "K153361", "K142362", "K153375", "K121608", "K123253", "K150270", "K200509", "K223503", "K142373", "K071480", "K191499", "K132492", "K953567", "K123364", "K072536", "K032844", "K113546", "K133156", "K021163", "K141463", "K110619", "K123983", "K991998", "K162298", "K102432", "K123131", "K110586", "K221817", "K091849", "K142351", "K162840", "K161831", "K133410", "K140554", "K141114", "K014030" ], "registration_number": [ "2032682", "2245285", "2032900", "3012963943", "3007118747", "9612316", "3011989923", "3007349751", "3010324880", "1319681", "8023018", "9680746", "2915274", "3002809144", "2182595", "3005360469", "3009518015", "2029372", "3005094123", "3009092698", "9610126", "2250051", "3021841051", "8031673", "2020726", "3003268355", "3007361513", "3010610113", "1063851", "1222302", "2517506", "2032087", "1219913", "2032839", "9615777", "3007111389", "3002642396", "3014862385", "3005333358", "8021924", "3002637618", "3005174594", "2432235", "3032705", "2244821", "3009335633", "3000308930", "2122870", "3022178699", "3002800697", "3005529799" ], "fei_number": [ "3004185580", "2245285", "3002808328", "3012963943", "3007118747", "3005670738", "3003952975", "3002807272", "3011989923", "3007349751", "3010324880", "2915274", "3002809144", "2182595", "3009518015", "3005094123", "3009092698", "2250051", "3021841051", "2967", "2020726", "3003268355", "3007361513", "3010610113", "3007034602", "3002806559", "2517506", "3004445302", "1219913", "1000306617", "1000121039", "1000136573", "3007111389", "3002642396", "3014862385", "1000206808", "3005333358", "3002485711", "3002637618", "3005174594", "3002701146", "2432235", "1000442352", "2244821", "3009335633", "3000308930", "2122870", "3022178699", "3002800697", "3005529799", "3003355251" ], "device_name": "System, Test, Vitamin D", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1825", "device_class": "2" } } ] }