Nova Biomedical recalls Prime Plus Analyzers due to potential erroneous creatinine results in early use. Affected units have specific part numbers and software versions. Consumers should contact for remedy.
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 Prime Plus Analyzers because new BUN/Creatinine Sensor Cartridges may report incorrect creatinine results within the first 2-4 hours of use. This could lead to inaccurate blood test results if not caught by standard quality checks.
The initial 2-4 hours after installing a new BUN/Creatinine Sensor Cartridge can cause the analyzer to report incorrect creatinine levels. Standard quality control checks may not detect this error during this early period.
Patients using the Prime Plus Analyzer for blood tests, especially those with kidney function monitoring. Healthcare providers using the device for clinical testing are most at risk.
Check for part numbers: 00385480574006 (original) or 00385480595087 (remanufactured). The device has software versions V1.17.1123.0 or V3.2.1123.0. The product is sold under the brand Nova Biomedical.
Look for part numbers 00385480574006 or 00385480595087 on the device.
Reach out to Nova Biomedical for specific remedy instructions as the recall remedy is not stated.
The analyzer may report incorrect creatinine results within the first 2-4 hours after installing a new BUN/Creatinine Sensor Cartridge.
Check for part numbers 00385480574006 (original) or 00385480595087 (remanufactured) and software versions V1.17.1123.0 or V3.2.1123.0.
Contact Nova Biomedical for specific remedy instructions as the recall remedy is not stated in the record.
We’ve drafted a message you can send Nova Biomedical to request your refund or repair — edit it as you like.
Subject: Recall Z-0207-2024 — Nova Biomedical Nova Biomedical Hello, I own a Nova Biomedical that is covered by recall Z-0207-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
