{ "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": "216317", "product_res_number": "Z-0366-2026", "event_date_initiated": "2025-09-22", "event_date_posted": "2025-10-27", "recall_status": "Open, Classified", "res_event_number": "97672", "product_code": "CEW", "k_numbers": [ "K013566" ], "product_description": "Assay: IMMULITE 2000 Intact PTH;\nTest Code: iPT;\nSiemens Material Number (SMN): (1) 10381441, (2) 10381442;\nCatalog Number: (1) L2KPP2, (2) L2KPP6;", "code_info": "1. Siemens Material Number (SMN): 10381441;\nCatalog Number: L2KPP2;\nUDI-DI: 00630414961910;\nLot Number: 385, ***Expanded 2/18/2026*** 387, 388, 389;  2. Siemens Material Number (SMN): 10381442; Catalog Number: L2KPP6; UDI-DI: 00630414961927; Lot Number: 385, ***Expanded 2/18/2026*** 387, 388, 389;", "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": "Jennifer Cacace\n802-430-2902", "reason_for_recall": "The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.", "root_cause_description": "Under Investigation by firm", "action": "On September 22, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers.\nCustomer Actions:\nPlease review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.\nDiscontinue use of and discard the kit lot listed in the table above (Products Section).\nComplete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days.\nFor continued Intact PTH testing in your laboratory during this time, please contact your Siemens representative to discuss alternative Siemens Healthineers solutions. As an alternative, customers who have an ADVIA Centaur system or an Atellica IM/CI may utilize the corresponding iPTH assay on those systems. These platforms are not impacted.\nPlease retain this letter with your laboratory records and forward this letter to those who may have received this product. A follow-up communication will be provided when assay performance has been restored.\n***Update 2/18/2026*** On February 10, 2026 Follow-up Urgent Medical Device Correction letters were sent to additional customers to notify of the addition of new lots for the recall. Customer actions remained the same as the original letter.", "product_quantity": "3318 units (169 US, 3149 OUS)", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AL, CA, DC, FL, ID, IN, LA, MD, NC, NJ, NY, PA, SC and the countries of Argentina, Australia, Bolivia, Bosnia Herzeg, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, Hungary, India, Iran, Israel, Italy, Kosovo, Kuwait, Latvia, Lebanon, Macedonia, Mexico, Nepal, Netherlands, P.R. China, Pakistan, Palestinian Ter, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovakia, Slovenia, South Africa, Spain, Taiwan, Tunisia, Turkey, Turkmenistan, U.A.E., Ukraine, Uruguay, Uzbekistan.", "openfda": { "k_number": [ "K811418", "K861797", "K133601", "K840379", "K944788", "K022603", "K232791", "K033727", "K874299", "K843870", "K001411", "K051810", "K011505", "K000471", "K150879", "K221197", "K013566", "K053533", "K843685", "K901711", "K020945", "K844735", "K771783", "K161158", "K821131", "K974306", "K101921", "K962598", "K992680", "K051141", "K022472", "K051150", "K060420", "K962033", "K132515", "K850254", "K942369", "K950211", "K853784", "K896294", "K004038", "K033426", "K992105", "K163658", "K031534", "K831470", "K070391", "K930008", "K822944", "K952199", "K843871", "K973514", "K013992", "K040813", "K051888", "K061190", "K103325", "K060348", "K820228", "K831069", "K903130", "K033302", "K813203", "K063232", "K921949", "K121981", "K830700", "K070709", "K782010", "K830664", "K791128", "K063605", "K882560", "K782081", "K970483", "K954418", "K921629", "K941878", "K833768", "K934760", "K231927", "K913434", "K772249", "K811566", "K190702", "K871970" ], "registration_number": [ "1036362", "3033967997", "2122870", "3009518015", "9612316", "3007118747", "2245285", "2182595", "3005529799", "3002809144", "2025099", "1222302", "2432235", "8021924", "9610126", "3022178699", "8023018", "3012963943", "3011989923", "3007111389", "1219913", "8031673", "1319681", "9610746", "3002642396", "8020888", "3000308930", "2250051", "3002800697", "2020726", "3005333358", "2032839", "9680746", "2517506", "3002806944", "3006198300" ], "fei_number": [ "3002806557", "1036362", "3033967997", "3002485711", "3002808328", "2122870", "3009518015", "3007118747", "2967", "2245285", "3002807272", "2182595", "3007019572", "3005529799", "3002809144", "2432235", "3004185580", "3007981058", "3022178699", "1000206808", "3012963943", "3011989923", "3007111389", "1219913", "3002642396", "3000308930", "2250051", "3002800697", "2020726", "3005333358", "1000121039", "1000136573", "2517506", "3002806944", "3006198300", "3002806559" ], "device_name": "Radioimmunoassay, Parathyroid Hormone", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1545", "device_class": "2" } } ] }