{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "203429", "product_res_number": "Z-0208-2024", "event_date_initiated": "2023-09-18", "event_date_posted": "2023-11-01", "recall_status": "Open, Classified", "res_event_number": "93095", "product_code": "JGS", "k_numbers": [ "K200403" ], "product_description": "Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma.\n\n(1) PN 63368 Stat Profile Prime Plus POC Analyzer\n(2) PN 63369 Stat Profile Prime Plus POC Analyzer, Remanufactured\n\n\nP/N: 57400, 63368", "code_info": "UDI-DI: N/A\n\nAll software versions:\nInternational Except China: W1.17.1123.0 and W3.2.1123.0\tV1.50.1123.0\nChina: V1.50.1123.0", "firm_fei_number": "1219029", "recalling_firm": "Nova Biomedical Corporation", "address_1": "200 Prospect St", "city": "Waltham", "state": "MA", "postal_code": "02453-3407", "additional_info_contact": "Theresa Austin\n781-647-3700", "reason_for_recall": "Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be identified by traditional Quality Control practices.", "root_cause_description": "Process design", "action": "Nova Biomedical Customer Success Managers starting 9/18/23 contacted consignees directly via telephone, to review the bulletin with the consignee DRP, verify an email to send the bulletin to them, and then immediately forward the bulletin to them so they can share within their own healthcare facility.\nLetter states the reason for recall, health risk and action to take:\nNova Biomedical recommends that your healthcare facility take one of the following risk mitigation steps after a BUN/Creatinine Sensor Cartridge replacement to reduce the possibility of this issue occurring in your facility until your analyzers have received a software update.\n\n\"\tIf your analyzer tests patient samples frequently, initiate a manual analyzer calibration every 30 minutes within the first 2 hours, and then every hour for the next 2 hours after cartridge replacement.\n\"\tIf your analyzer tests patient samples infrequently, within the first 4 hours after cartridge replacement, initiate a manual analyzer calibration prior to performing a patient test.\nUntil your Prime Plus analyzer(s) software is updated, if your healthcare facility experiences an erroneous creatinine result or adverse event after a new sensor cartridge installation, Nova encourages you to contact Nova Biomedical or your authorized distributor to properly document the incident. For adverse event(s), Nova encourages you to report the details using the MedWatch Online Voluntary Reporting Form, MedWatch Online Voluntary Reporting Form (fda.gov).\n\nINTERNAL HEALTHCARE FACILITY COMMUNICATION:\n\nThis Field Correction Notice should be distributed to all those within your organization who need to be aware of this issue. Please notify other parties affiliated with your organization, which are affected by this notice. Please maintain awareness of this notice until the issue has been corrected with a scheduled software update. \nIf you have any questions on the contents of this notice, would like to discuss other risk mitigation options", "product_quantity": "161 units", "distribution_pattern": "Nationwide\nForeign:\nCountry\nAlgeria\nAustralia\nAustria\nBangladesh\nBenin\nBolivia\nBrazil\nCanada\nChile\nChina\nColombia\nCroatia\nCYPRUS\nCzech Republic\nEcuador\nEgypt\nEl Salvador\nFinland\nFrance\nGermany\nGreece\nGuatemala\nIndia\nIndonesia\nIreland\nIsrael\nItaly\nJapan\nJORDAN\nKazakhstan\nKenya\nKurdistan, Iraq\nKuwait\nMalaysia\nMalta\nMexico\nMoldova\nMorocco\nNepal\nNetherlands\nNew Zealand\nOman\nPakistan\nPalestine\nParaguay\nParaquay\nPeru\nPhilippines\nPoland\nPuerto Rico\nQatar\nRepublic of Panama\nRomania\nRussia\nRwanda\nSaudi Arabia\nSerbia\nSlovenia\nSouth Africa\nSouth Korea\nSpain\nSri Lanka\nSudan\nSweden\nSwitzerland\nSyria\nThailand\nTrinidad\nTrinidad,W.I.\nTunisia\nUK\nUkraine\nUnited Arab Emerites\nUruguay\nVietnam", "openfda": { "k_number": [ "K011213", "K963763", "K230275", "K770601", "K830589", "K895936", "K001154", "K830588", "K100829", "K894035", "K961099", "K962334", "K912560", "K864872", "K023049", "K955374", "K941400", "K102647", "K053165", "K904335", "K924471", "K880750", "K870183", "K220977", "K915176", "K863521", "K081411", "K844587", "K924547", "K901042", "K123726", "K172232", "K020364", "K842025", "K992844", "K874185", "K832415", "K000895", "K061597", "K002407", "K892500", "K963542", "K922215", "K940194", "K802155", "K100673", "K850209", "K925612", "K161837", "K872190", "K833992", "K925611", "K811289", "K843453", "K832070", "K840557", "K801882", "K864862", "K121140", "K921718", "K862819", "K841417", "K132418", "K801011", "K002855", "K140373", "K923806", "K853832", "K935120", "K200403", "K181201", "K905264", "K874832", "K873126", "K161954", 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