{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "192233", "product_res_number": "Z-0830-2022", "event_date_initiated": "2022-01-28", "event_date_created": "2022-03-28", "recall_status": "Open, Classified", "res_event_number": "89697", "product_code": "JGJ", "k_numbers": [ "K140790" ], "product_description": "Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. \n\nThe Dimension Vista Magnesium Flex Reagent (MG) method is an In vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma, and urine on the Dimension Vista System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypomagnesemia (abnormally high plasma levels of magnesium).", "code_info": "[lot 21253BB, UDI: 0084276801569421253BB22091010445158840], [lot 21263BA \tUDI: 0084276801569421263BA22092010445158840], [lot 21335AA, UDI: 0084276801569421335AA22120110445158840]", "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": "Siemens Healthineers Remote Services Center\n800-441-9250", "reason_for_recall": "Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential for QC failures or erroneous patient results which may lead to repeat and follow-up testing.", "root_cause_description": "Under Investigation by firm", "action": "The firm, Siemens Healthineers, sent \"URGENT MEDICAL DEVICE CORRECTION\" (VC-22-01.A.US) on 01/28/2022 via Fed Ex to all customers to inform them of the issue and instruct them to discontinue use and discard the affected lots. Complete and return the Field Correction Effectiveness Check Form via email at uscctsfcaecfax.team@siemens-healthineers.com or fax to: (312) 275-7795. \n\nAt the present time, Siemens has no replacement lots to offer customers. Siemens \nsuggests using an alternate methodology for magnesium until a replacement lot is \navailable.\n \nIf 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. \n\nReplacement kits will be provided when a new lot is available.\n\nIf you have any questions, please contact your Siemens Healthineers Remote Services Center or your local Siemens Healthineers Technical Support Representative.", "product_quantity": "14220 (US 13305, OUS 915)", "distribution_pattern": "Worldwide distribution: US (nationwide) 47 States including: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY) and OUS countries of: Australia, Canada and Netherlands.", "openfda": { "k_number": [ "K040508", "K863069", "K883972", "K923411", "K901124", "K991717", "K903341", "K800327", "K883326", "K981192", "K870553", "K880880", "K162399", "K882256", "K852005", "K883170", "K863002", "K930074", "K981791", "K092737", "K873180", "K030010", "K091910", "K853853", "K903306", "K843893", "K820976", "K891355", "K881300", "K860215", "K924658", "K063208", "K012326", "K885022", "K874822", "K901265", "K944202", "K821102", "K884600", "K853592", "K792399", "K890798", "K920603", "K902919", "K874506", "K861668", "K162200", "K844278", "K841259", "K850381", "K834075", "K935183", "K872311", "K974606", "K964915", "K870370", "K912321", "K912825", "K874847", "K952426", "K803088", "K983416", "K802091", "K913764", "K943001", "K894508", "K944407", "K840784", "K874576", "K111915", "K003835", "K873530", "K122302", "K843031", "K855190", "K991761", "K040115", "K771469", "K883967", "K874595", "K901758", "K173294", "K923927", "K181748", "K905544", "K810084", "K861386", "K851657", "K921677", "K926144" ], "registration_number": [ "2432235", "3006198300", "1000403749", "2050012", "2030861", "3014607865", "2517506", "3002642396", "2250051", "3000308930", "3005094123", "3004493545", "1218882", "1319681", "3012963943", "1319808", "3010939897", "3004438098", "9680746", "1220972", "3005146313", "1319809", "3013660430", "1832216", "8020316", "3000148879", "3011989923", "9610529", "3016438761", "1827821", "2050010", "3003795116", "3003593973", "2247288", "3002809144", "1616487", "3010825766", "2939693", "2085064", "3007662974", "1181121", "3009473156", "3005333358", "8040374", "9610126" ], "fei_number": [ "2432235", "3006198300", "3002806809", "1000403749", "2050012", "3014607865", "1000136573", "2517506", "3002642396", "2250051", "3000308930", "3005094123", "3004493545", "1218882", "5864", "3012963943", "1000305840", "3010939897", "3004438098", "1000135102", "1000206808", "1220972", "3005146313", "3013660430", "1832216", "3000148879", "3011989923", "3016438761", "1827821", "1000122044", "2050010", "3002806559", "3003795116", "3003593973", "3000215862", "3002809144", "1000305841", "3010825766", "2939693", "1616487", "3007662974", "1181121", "3002806560", "3009473156", "3005333358" ], "device_name": "Photometric Method, Magnesium", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1495", "device_class": "1" } } ] }