{ "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": "204468", "product_res_number": "Z-0606-2024", "event_date_initiated": "2023-10-26", "event_date_posted": "2023-12-21", "recall_status": "Open, Classified", "res_event_number": "93473", "product_code": "JIX", "k_numbers": [ "K122398" ], "product_description": "RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood.\nSMN: 10844813", "code_info": "UDI-DI: 00630414947556\nAll serial numbers", "firm_fei_number": "3002637618", "recalling_firm": "Siemens Healthcare Diagnostics Inc", "address_1": "2 Edgewater Dr", "city": "Norwood", "state": "MA", "postal_code": "02062-4637", "additional_info_contact": "SAME\n781-269-3000", "reason_for_recall": "RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary intervention for hyponatremia and result in iatrogenic hypernatremia especially if the true sodium result is near the thresholds of severe alterations, as well as cause a Question Result -----? error flag for multiple electrolytes on patient samples and quality control that may cause a delay of diagnosis or treatment.", "root_cause_description": "Under Investigation by firm", "action": "Siemens Healthineers issued Urgent Medical Device Correction POC 24-004.A.US on November 1, 2023 to US customers. Letter states reason for recall, health risk and action to take:\nPlease review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.\nIf you experience this issue, you may request a no-charge replacement or receive a credit\nfrom your local Siemens Healthineers representative.\nComplete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days.\nPlease retain this letter with your laboratory records and forward this letter to those who\nmay have received this product.\n\nWe apologize for the inconvenience this situation may cause. Siemens Healthineers is conducting a comprehensive evaluation with a cross-functional team to promptly resolve the issue with utmost priority. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.\n\nHealth Products Regulatory Authority (HPRA) has been notified by the Siemens\nAuthorized Representative in Ireland. Local representatives for EU and non-EU regions\nhave also been notified of this Urgent Field Safety Notice (OUS Version) and will follow\nlocal requirements for contacting their respective National Competent Authorities to\nadvise them of the issue.", "product_quantity": "0 cartridges US", "distribution_pattern": "Nationwide with Worldwide Distribution to: \nAlbania\nAlgeria\nAngola\nArgentina\nArmenia\nAustralia\nAustria\nAzerbaijan\nBahrain\nBangladesh\nBelarus\nBelgium\nBolivia\nBosnia and Herzegovina\nBotswana\nBrazil\nBrunei Darussalam\nBulgaria\nBurkina Faso\nCambodia\nCanada\nChile\nChina\nColombia\nCongo, Republic\nCosta Rica\nC¿te dIvoire\nCroatia\nCura¿ao\nCzech Republic\nDenmark\nEcuador\nEgypt\nEstonia\nFiji\nFinland\nFrance\nFrench Polynesia\nGeorgia\nGermany\nGhana\nGreece\nGuadeloupe\nHonduras\nHong Kong\nHungary\nIceland\nIndia\nIndonesia\nIran, Islamic Republic 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