{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "195972", "product_res_number": "Z-1816-2022", "event_date_initiated": "2022-08-17", "event_date_posted": "2022-09-26", "recall_status": "Open, Classified", "res_event_number": "90825", "product_code": "JGJ", "k_numbers": [ "K861700" ], "product_description": "Dimension Magnesium (MG) Flex reagent cartridge\nSiemens\nMaterial Number (SMN)/REF (Catalog Number):10444963/DF57", "code_info": "Lot Number: UDI\nMG lot FA2350\t10444963\t00842768014185FA235022121610444963840;\nMG lot FA2356\t10444963\t00842768014185FA235622122210444963840;\nMG lot GA2363\t10444963\t00842768014185GA236322122910444963840;\nMG lot FA3019\t10444963\t00842768014185FA301923011910444963840", "firm_fei_number": "2517506", "recalling_firm": "Siemens Healthcare Diagnostics, Inc.", "address_1": "500 Gbc Dr", "city": "Newark", "state": "DE", "postal_code": "19702-2466", "additional_info_contact": "SAME\n800-441-9250", "reason_for_recall": "Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be\nproduced in the absence of an Abnormal Reaction flag. Based on customer data, imprecision leading to erroneous, unflagged patient results with a bias of -15 to -59% may occur", "root_cause_description": "Under Investigation by firm", "action": "Siemens Healthineers issued to US Customers Urgent Medical Device Correction (VC-22-01.B.US) on 8/17/22 via Fed'X and OUS Customers sent Urgent Field Safety Notice (VC-22-01.B.OUS) to inform them to discontinue use and discard Dimension MG lots FA2350, FA2356, GA2363, and FA3019. Letter states reason for recall, health risk and action t take:\nDiscontinue use and discard Dimension MG lots listed in Table 1.\n Review your inventory of these products to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities.\n Please review this letter with your Medical Director.\nComplete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days.\n If you received any complaints of illness or adverse events associated with the products\nlisted in Table 1, immediately contact your local Siemens Remote Services Center or your\nlocal Siemens Technical Support Representative.\nPlease retain this letter with your laboratory records and forward this letter to those who may have received this product.\n If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers\ntechnical support representative", "product_quantity": "26851 units", "distribution_pattern": "Nationwided\n \nForeign:\nAfghanistan¿¿¿¿\nAlbania¿¿¿¿¿¿¿¿\nAustria¿¿¿¿¿¿¿¿\nBahrain¿¿¿¿¿¿¿¿\nBosnia¿Herzeg.¿\nBulgaria¿¿¿¿¿¿¿\nCanada\nCroatia¿¿¿¿¿¿¿¿\nCzech¿Republic¿\nEgypt¿¿¿¿¿¿¿¿¿¿\nFrance¿¿¿¿¿¿¿¿¿\nGeorgia¿¿¿¿¿¿¿¿\nGermany¿¿¿¿¿¿¿¿\nGreece¿¿¿¿¿¿¿¿¿\nHungary¿¿¿¿¿¿¿¿\nIsrael¿¿¿¿¿¿¿¿¿\nItaly¿¿¿¿¿¿¿¿¿¿\nJordan¿¿¿¿¿¿¿¿¿\nKazakhstan¿¿¿¿¿\nKenya¿¿¿¿¿¿¿¿¿¿\nKuwait¿¿¿¿¿¿¿¿¿\nLatvia¿¿¿¿¿¿¿¿¿\nLebanon¿¿¿¿¿¿¿¿\nMacedonia¿¿¿¿¿¿\nMali¿¿¿¿¿¿¿¿¿¿¿\nMalta¿¿¿¿¿¿¿¿¿¿\nMontenegro¿¿¿¿¿\nMorocco¿¿¿¿¿¿¿¿\nNepal¿¿¿¿¿¿¿¿¿¿\nNetherlands¿¿¿¿\nPakistan¿¿¿¿¿¿¿\nPoland¿¿¿¿¿¿¿¿¿\nPortugal¿¿¿¿¿¿¿\nQatar¿¿¿¿¿¿¿¿¿¿\nRomania¿¿¿¿¿¿¿¿\nRussian¿Fed.¿¿¿\nSaudi¿Arabia¿¿¿\nSenegal¿¿¿¿¿¿¿¿\nSerbia¿¿¿¿¿¿¿¿¿\nSlovakia¿¿¿¿¿¿¿\nSlovenia¿¿¿¿¿¿¿\nSpain¿¿¿¿¿¿¿¿¿¿\nSudan¿¿¿¿¿¿¿¿¿¿\nSwitzerland¿¿¿¿\nTurkey¿¿¿¿¿¿¿¿¿\nU.A.E.¿¿¿¿¿¿¿¿¿\nUganda¿¿¿¿¿¿¿¿¿\nUkraine¿¿¿¿¿¿¿¿\nUnited¿Kingdom¿\nUzbekistan¿¿¿¿¿", "openfda": { "k_number": [ "K092737", "K852005", "K860215", "K964915", "K872311", "K840784", "K935183", "K863002", "K901758", "K855190", "K850381", "K861668", "K820976", "K991717", "K943001", "K800327", "K894508", "K874595", "K974606", "K952426", "K891355", "K981192", "K903306", "K883170", "K874576", "K912825", "K983416", "K874506", "K063208", "K122302", "K792399", "K834075", "K912321", "K040115", "K905544", "K921677", "K901265", "K874822", "K923927", "K091910", "K853592", "K853853", "K944407", "K926144", "K874847", "K913764", "K880880", "K873530", "K771469", "K861386", "K881300", "K885022", "K803088", "K890798", "K920603", "K991761", "K843893", "K884600", "K883967", "K012326", "K173294", "K883972", "K944202", "K851657", "K981791", "K040508", "K821102", "K924658", "K844278", "K902919", "K841259", "K162200", "K901124", "K870370", "K870553", "K181748", "K883326", "K003835", "K162399", "K111915", "K030010", "K873180", "K903341", "K802091", "K882256", "K923411", "K930074", "K863069", "K843031", "K810084" ], "registration_number": [ "1319809", "3011989923", "3000308930", "1218882", "8020316", "3013660430", "2030861", "3014607865", "3003593973", "2050012", "9610529", "3005146313", "2939693", "3005094123", "3009473156", "9680746", "3005333358", "2250051", "3002642396", "2050010", "2517506", "3002809144", "3010939897", "2085064", "1319681", "3003795116", "1319808", "1000403749", "9610126", "1827821", "3004493545", "3000148879", "1181121", "3012963943", "3007662974", "3004438098", "3006198300", "3010825766", "3016438761", "2247288", "1616487", "1220972", "1832216", "8040374", "2432235" ], "fei_number": [ "3011989923", "1000305840", "3000308930", "5864", "1218882", "3013660430", "2050012", "3002806560", "3003593973", "3014607865", "3005146313", "2939693", "3005094123", "1000135102", "3009473156", "3005333358", "3002806809", "2250051", "3002642396", "2050010", "2517506", "3002809144", "3010939897", "3003795116", "1000403749", "1000136573", "1827821", "3004493545", "3000148879", "1181121", "1000206808", "3002806559", "3012963943", "3007662974", "3004438098", "3006198300", "3010825766", "3016438761", "1616487", "1220972", "1832216", "3000215862", "2432235", "1000305841", "1000122044" ], "device_name": "Photometric Method, Magnesium", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1495", "device_class": "1" } } ] }