{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216719", "product_res_number": "Z-0493-2026", "event_date_initiated": "2025-10-06", "event_date_posted": "2025-11-13", "recall_status": "Open, Classified", "res_event_number": "97819", "product_code": "DHB", "k_numbers": [ "K021208" ], "product_description": "Food Panel 3 Specific Allergen;\nSiemens Material Number (SMN): 10385891;\nCatalog Number: FP3L4;", "code_info": "Siemens Material Number (SMN): 10385891;\nModel/Catalog: FP3L4;\nUDI-DI: 00630414960418;\nLot number: 629;", "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": "Karen Confort\n508-668-5000", "reason_for_recall": "The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.", "root_cause_description": "Under Investigation by firm", "action": "On October 6, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. \nCustomer Actions\nPerform the instructions provided below:\n\" Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.\n\" Discontinue use of and discard IMMULITE 2000 Oak Mix Specific Allergen Lot 627.\n\" Review your inventory of the product to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities.\n\" Complete and return the Field Correction Effectiveness Check Form attached to this letter within 7 days.\n\" Please retain this letter with your laboratory records and forward this letter to those who may have received this product.\nResolution\nThe issue is resolved with the next available lot of IMMULITE 2000 Oak Mix Specific Allergen. It is anticipated that the replacement lot will be available by mid-November 2025.\nWe apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Custom", "product_quantity": "28 units (OUS only)", "distribution_pattern": "Worldwide - US Nationwide distribution in the state of CA and the countries of Argentina, Australia, Austria, Belgium, Bosnia Herzeg. , Brazil, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Estonia, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Israel, Italy, Latvia, Macedonia, Mexico, Netherlands, Norway, Pakistan, Panama, Poland, Portugal, Romania, Russian Fed., Serbia, Slovakia, Spain, Sweden, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay.", "openfda": { "k_number": [ "K863844", "K862176", "K873486", "K935876", "K874169", "K182479", "K873770", "K242531", "K823593", "K862264", "K924209", "K896902", "K953780", "K832217", "K260591", "K843694", "K121156", "K151029", "K873406", "K891135", "K880001", "K872280", "K941278", "K864104", "K945748", "K101251", "K962274", "K840537", "K851273", "K831554", "K880547", "K913892", "K083314", "K962976", "K173726", "K013135", "K802556", "K904661", "K830155", "K830170", "K965094", "K912294", "K862938", "K923420", "K924044", "K972068", "K871660", "K021208", "K871684", "K860027", "K904330", "K260280", "K051218", "K091289", "K850895", "K926420", "K941057", "K112523", "K875163", "K874717", "K893132", "K830096", "K831091", "K100999", "K910075", "K191510", "K874446", "K123275", "K831045", "K131738", "K862173", "K091984", "K852794", "K870625", "K851512", "K925044", "K894227", "K922538", "K090257", "K261027", "K193613", "K884923", "K873969", "K252775", "K823470", "K905176", "K873814", "K931746", "K861184", "K100910", "K914685", "K112910", "K943768", "K121463", "K903637", "K845032", "K954566", "K853456", "K913150", "K822141", "K113841", "K896694", "K842457", "K953014", "K863098", "K834598", "K941993", "K871599", "K875168", "K883537", "K132801", "K872946", "K870966", "K913833", "K200825", "K023152", "K883371", "K883273", "K874540", "K905054", "K885269", "K854865", "K934524", "K914554", "K000132", "K870597", "K871331", "K875329", "K874440", "K982343", "K913212", "K771578", "K880002", "K875125", "K863973", "K880221", "K092050", "K935488", "K840670", "K863743", "K122197", "K021206", "K862266", "K880160", "K910292", "K911903", "K212181", "K983954", "K875244", "K852263", "K863794", "K862265", "K820029", "K190315", "K880168", "K880899", "K921574", "K810462", "K950728", "K081217", "K823592", "K875274", "K881899", "K961889", "K150597", "K972364", "K874281", "K875110", "K896592", "K853969", "K863967", "K885065", "K862901", "K870264", "K923284", "K092978", "K874883", "K870152", "K884501", "K111919", "K863355", "K880003", "K896852", "K854939", "K875066", "K873193", "K840876", "K071913", "K873648", "K080322", "K884883", "K093107", "K874150", "K163370", "K852189", "K950629", "K871723", "K884185", "K883666", "K013134", "K831442", "K875328", "K905636", "K200279", "K892409", "K093987", "K880415", "K902576", "K894190", "K991048", "K252493", "K864696", "K912582", "K924119", "K925425", "K083853", "K910517", "K150854", "K914959", "K974580", "K051677", "K260059", "K941564", "K855053", "K870624", "K834526", "K833885", "K220162", "K880567", "K914850", "K894253", "K873998", "K841516", "K973186", "K832344", "K182793", "K870153", "K993388", "K874168", "K863123", "K812414", "K840360", "K974350", "K081830", "K863394", "K874149", "K963245", "K874802", "K030590", "K821451", "K854756", "K844629", "K020387", "K833418", "K873676", "K897145", "K883616", "K863036", "K905162", "K862175", "K843302", "K870009", "K862939", "K101572", "K903742", "K873112", "K880187", "K945884" ], "registration_number": [ "3004973408", "3006198300", "1036362", "2016473", "3002806944", "2517506", "2432235", "3013521527", "3039353646", "9610865", "3003477135", "9610566", "2029275", "1423662", "3031570369", "2936856", "2022994" ], "fei_number": [ "3002807876", "3004973408", "3006198300", "1036362", "3002806350", "3002806944", "1000306431", "2517506", "3013521527", "2432235", "3039353646", "3003477135", "1000125787", "3000215273", "3031570369", "2936856", "2022994" ], "device_name": "System, Test, Radioallergosorbent (Rast) Immunological", "medical_specialty_description": "Immunology", "regulation_number": "866.5750", "device_class": "2" } } ] }