The Recall Desk
HighFDA (Devices)·Z-0207-2024·Announced 2023-11-08

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.

What this means for you

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
Category
Medical Device — Blood Gas Analyzer
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 →

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Same manufacturer · Nova Biomedical Corporation

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