Nova Biomedical recalls its Stat Profile Prime Plus POC Analyzer due to potential erroneous creatinine results in the first 2-4 hours after new sensor cartridge installation. Affected units have specific model numbers and software versions.
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.
Nova Biomedical is recalling its Stat Profile Prime Plus POC Analyzer because it may report incorrect creatinine results during the first 2-4 hours after installing a new BUN/Creatinine Sensor Cartridge. This could lead to inaccurate blood test results if the device is used without proper quality checks.
The device may report incorrect creatinine levels when a new BUN/Creatinine Sensor Cartridge is first installed. This error can only be detected within the first 2-4 hours after installation and may not be caught by standard quality control checks.
Healthcare professionals using the device for blood tests are most at risk. Patients receiving blood tests with this device may experience inaccurate results if the device is used without proper quality checks.
Check for model numbers 63368 or 63369 (remanufactured) with software versions W1.17.1123.0 or W3.2.1123.0 (international) or V1.50.1123.0 (China).
Identify the model number on your device (63368 or 63369) and software version.
Ensure your device has the specific software versions listed in the recall notice.
The device may report incorrect creatinine results during the first 2-4 hours after installing a new BUN/Creatinine Sensor Cartridge, which may not be detected by standard quality checks.
Check for model numbers 63368 or 63369 with software versions W1.17.1123.0 or W3.2.1123.0 (international) or V1.50.1123.0 (China).
The recall does not include a specific remedy; check the device model and software version to determine if it is affected.
We’ve drafted a message you can send Nova Biomedical to request your refund or repair — edit it as you like.
Subject: Recall Z-0208-2024 — Nova Biomedical Nova Biomedical Hello, I own a Nova Biomedical that is covered by recall Z-0208-2024 from Nova Biomedical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
