Blood Gas Analyzer Software Issue Causes Erroneous Creatinine Results During Startup
Nova Biomedical Prime Plus Analyzers may report incorrect creatinine levels during the first 2-4 hours after installing a new sensor cartridge. These errors may not be identified by traditional quality control practices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II recall with potential for erroneous patient results during device startup. No illnesses or injuries have been reported. The hazard is risk-of-harm (incorrect lab values), but without reported incidents, the score is limited to High per the rubric.
Plain-English summary
Nova Biomedical Prime Plus Analyzers (1,779 units: 438 in the United States, 1,341 distributed internationally) are the subject of a Class II recall due to a potential software issue.
The analyzer may report erroneous (incorrect) creatinine patient results when a new BUN/Creatinine Sensor Cartridge is first installed. This potential error exists within the first 2-4 hours after cartridge installation and may not be identified by traditional quality control practices.
Affected units include the Stat Profile Prime Plus Analyzer (product numbers 57400 and 59508) with software versions V1.17.1123.0 or V3.2.1123.0. The device is intended to measure certain gases in blood, serum, plasma and pH levels.
The recalled product
- Product
- Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57400 Stat Profile Prime Plus Analyzer (2) PN 59508 Stat Profile Prime Plus Analyzer, Remanufactured
- Manufacturer
- Nova Biomedical Corporation
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Nova Biomedical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Nova Biomedical Corporation
See all →- CriticalNova StatStrip Glucose Hospital Meter System Recalled for Software Defect
FDA (Devices) · 2026-09-23
- CriticalNova Biomedical Recalls StatStrip Glucose Meters Due to Software Defect
FDA (Devices) · 2026-09-23
- SevereNova Biomedical StatStrip Glucose Hospital Meter System Recalled for Software Defect
FDA (Devices) · 2026-09-23
- SevereNova Biomedical Recalls StatStrip Glucose Meters Due to Software Defect
FDA (Devices) · 2026-09-23
- SevereNova Biomedical StatStrip Glucose Meter Recalled for Data Error
FDA (Devices) · 2026-09-23
Similar recalls
- HighNova Biomedical Stat Profile Prime Analyzer Software Recall
FDA (Devices) · 2017-07-19
- HighBlood Gas Analyzer Cartridges Recalled for Potential Oxygen Measurement Errors
FDA (Devices) · 2023-11-29
- HighBlood Gas Analyzer Cartridges Recalled for Falsely Elevated Oxygen Readings
FDA (Devices) · 2023-11-29
- SevereBlood glucose ketone meter software bug causes erroneous result transmission
FDA (Devices) · 2025-01-01
- SevereBlood Glucose Ketone Meter Firmware Bug Causes Inaccurate Test Results
FDA (Devices) · 2025-01-01
- HighMedical Device Cartridges Recalled for Blood Oxygen Reading Errors
FDA (Devices) · 2023-11-29