{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "197087", "product_res_number": "Z-0716-2023", "event_date_initiated": "2022-11-04", "event_date_posted": "2022-12-15", "recall_status": "Open, Classified", "res_event_number": "91164", "product_code": "DHB", "k_numbers": [ "K101572" ], "product_description": "IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. \nSiemens Material Number (SMN): 10708840\nFor in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.", "code_info": "UDI-DI\n (01)00630414982939(10)D830(17)20221130;\n (01)00630414982939(10)D831(17)20221130; \n (01)00630414982939(10)D832(17)20221130; \n (01)00630414982939(10)D833(17)20221130.\nLot Numbers: D830, D831, D832, D833", "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": "Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result", "root_cause_description": "Under Investigation by firm", "action": "Siemens initiated issued on 11/04/2022 an Urgent Medical Device Correction (UMDC) IMC 23-01.A.US to US customers, an Urgent Field Safety Notice (UFSN) IMC 23-01.A-1.OUS to Outside the US (OUS, except Japan) customers, and an Urgent Field Safety Notice (UFSN) IMC 23-01.A-2.OUS (Japan) to customers in Japan . Letter states reason for recall, health risk and action to take:\nPlease review this letter with your Medical Director.\nDiscontinue use of the kit lots listed in Table 1.\nReview your inventory of this product to determine your laboratory s replacement needs and to provide information to Siemens for reporting to the authorities.\nComplete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days.\nIf you have received any complaints of illness or adverse events associated with the\nproduct listed in Table 1, immediately contact your local Siemens Healthineers Customer\nCare Center or your local Siemens Healthineers technical support representative.\nPlease retain this letter with your laboratory records and forward this letter to those who may have received this product. \nContact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative", "product_quantity": "1000 kits", "distribution_pattern": "Worldwide distribution. US Nationwide, Argentina¿¿¿¿¿¿\nAustralia¿¿¿¿¿¿\nAustria¿¿¿¿¿¿¿¿\nAzerbaijan¿¿¿¿¿\nBelgium¿¿¿¿¿¿¿¿\nBrazil¿¿¿¿¿¿¿¿¿\nChile¿¿¿¿¿¿¿¿¿¿\nColombia¿¿¿¿¿¿¿\nCosta¿Rica¿¿¿¿¿\nCroatia¿¿¿¿¿¿¿¿\nCzech¿Republic¿\nDenmark¿¿¿¿¿¿¿¿\nEcuador¿¿¿¿¿¿¿¿\nEgypt¿¿¿¿¿¿¿¿¿¿\nEstonia¿¿¿¿¿¿¿¿\nFrance¿¿¿¿¿¿¿¿¿\nGermany¿¿¿¿¿¿¿¿\nGuatemala¿¿¿¿¿¿\nHong¿Kong¿¿¿¿¿¿\nHungary¿¿¿¿¿¿¿¿\nIndonesia¿¿¿¿¿¿\nIsrael¿¿¿¿¿¿¿¿¿\nItaly¿¿\nJapan¿¿¿¿¿¿¿¿\nLatvia¿¿¿¿¿¿¿¿¿\nLithuania¿¿¿¿¿¿\nMacedonia¿¿¿¿¿¿\nMexico¿¿¿¿¿¿¿¿¿\nNetherlands¿¿¿¿\nNorway¿¿¿¿¿¿¿¿¿\nPakistan¿¿¿¿¿¿¿\nPanama¿¿¿¿¿¿¿¿¿\nParaguay¿¿¿¿¿¿¿\nPhilippines¿¿¿¿\nPoland¿¿¿¿¿¿¿¿¿\nPortugal¿¿¿¿¿¿¿\nRomania¿¿¿¿¿¿¿¿\nRussian¿Fed.¿¿¿\nSerbia¿¿¿¿¿¿¿¿¿\nSlovakia¿¿¿¿¿¿¿\nSlovenia¿¿¿¿¿¿¿\nSouth¿Africa¿¿¿\nSpain¿¿¿¿¿¿¿¿¿¿\nSweden¿¿¿¿¿¿¿¿¿\nSwitzerland¿¿¿¿\nTaiwan¿¿¿¿¿¿¿¿¿\nTurkey¿¿¿¿¿¿¿¿¿\nUkraine¿¿¿¿¿¿¿¿\nUnited¿Kingdom¿\nUruguay, and Uzbekistan¿¿¿¿¿", "openfda": { "k_number": [ "K080322", "K874540", "K982343", "K832344", "K873406", "K831442", "K862939", "K896852", "K873969", "K111919", "K924119", "K852794", "K896694", "K871599", "K852263", "K810462", "K923420", "K874169", "K855053", "K914959", "K840670", "K071913", "K913150", "K841516", "K896592", "K252493", "K842457", "K903742", "K941057", "K941564", "K051677", "K820029", "K862938", "K802556", "K862173", "K880168", "K131738", "K883537", "K023152", "K862264", "K875329", "K851512", "K821451", "K173726", "K870625", "K902576", "K083314", "K862266", "K953014", "K941993", "K853969", "K884501", "K874440", "K870597", "K926420", "K880221", "K091984", "K822141", "K831045", "K871684", "K953780", "K101251", "K874168", "K830170", "K921574", "K834526", "K870153", "K163370", "K874883", "K934524", "K875168", "K121156", "K182793", "K093987", "K874281", "K823470", "K122197", "K884185", "K880001", "K873486", "K840360", "K830096", "K190315", "K974580", "K891135", "K897145", "K863794", "K961889", "K922538", "K924044", "K905054", "K112523", "K963245", "K950629", "K851273", "K200279", "K212181", "K894190", "K863973", "K880187", "K913892", "K191510", "K884923", "K880567", "K852189", "K863967", "K150854", "K000132", "K885065", "K854756", "K874149", "K941278", "K862265", "K874150", "K863098", "K905176", "K954566", "K880547", "K875125", "K912294", "K081217", "K880415", "K840876", "K935876", "K973186", "K910292", "K863394", "K853456", "K083853", "K884883", "K943768", "K893132", "K113841", "K242531", "K220162", "K903637", "K871331", "K871660", "K843694", "K862175", "K873814", "K880899", "K150597", "K935488", "K013134", "K823592", "K873648", "K081830", "K880003", "K092978", "K843302", "K870264", "K863743", "K950728", "K260591", "K875328", "K771578", "K962976", "K100910", "K021208", "K870152", "K823593", "K091289", "K123275", "K182479", "K020387", "K896902", "K875066", "K844629", "K862901", "K090257", "K931746", "K862176", "K864104", "K830155", "K845032", "K910075", "K923284", "K132801", "K911903", "K860027", "K101572", "K030590", "K972364", "K833885", "K925425", "K874802", "K871723", "K873770", "K093107", "K924209", "K914554", "K881899", "K874446", "K972068", "K874717", "K875163", "K945748", "K925044", "K913833", "K840537", "K193613", "K991048", "K883371", "K870009", "K112910", "K854865", "K863844", "K875110", "K883273", "K880160", "K983954", "K873998", "K904330", "K831554", "K812414", "K100999", "K870966", "K092050", "K873193", "K945884", "K875274", "K870624", "K260059", "K880002", "K260280", "K252775", "K833418", "K863123", "K910517", "K965094", "K912582", "K993388", "K914685", "K200825", "K914850", "K831091", "K892409", "K832217", "K850895", "K151029", "K021206", "K863355", "K864696", "K974350", "K261027", "K121463", "K872946", "K883616", "K051218", "K883666", "K904661", "K834598", "K854939", "K873676", "K013135", "K861184", "K913212", "K863036", "K894227", "K872280", "K905162", "K885269", "K894253", "K875244", "K873112", "K962274", "K905636" ], "device_name": "System, Test, Radioallergosorbent (Rast) Immunological", "medical_specialty_description": "Immunology", "regulation_number": "866.5750", "device_class": "2", "registration_number": [ "3004973408", "3013521527", "9610566", "3003477135", "2432235", "3031570369", "9610865", "2022994", "1036362", "2517506", "3002806944", "3039353646", "1423662", "2029275", "2016473", "2936856", "3006198300" ], "fei_number": [ "3002806350", "3004973408", "3013521527", "3003477135", "2432235", "1000306431", "2022994", "1036362", "1000125787", "2517506", "3002806944", "3039353646", "3002807876", "3000215273", "3031570369", "2936856", "3006198300" ] } } ] }