Nova Biomedical Stat Profile Prime Analyzer Software Recall
Nova Biomedical is recalling Stat Profile Prime Analyzers because a software defect could cause scheduled quality control tests to overwrite pending patient results.
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: The recall is classified as FDA Class II. The hazard involves the potential for incorrect patient results due to data overwriting, which is a risk-of-harm scenario where specific injuries or illnesses have not yet been reported in the source text.
Plain-English summary
Nova Biomedical Corporation is recalling the Stat Profile Prime Analyzer, including ABG, CCS, and CCS Comp models, due to a software defect. The issue affects all current software versions of the devices.
The defect allows a scheduled A-QC (Automatic Quality Control) analysis to initiate before an operator releases a patient result. This can result in the pending patient result being overwritten with the A-QC test results, potentially leading to incorrect data being available for clinical decision-making.
The recall involves 1,083 units distributed worldwide, including 179 units in the United States and 904 units in foreign countries. Users should contact Nova Biomedical Corporation for instructions on how to resolve the software issue.
The recalled product
- Product
- Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime…
- Manufacturer
- Nova Biomedical Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All current software versions
Distribution
Distributed nationwide across the United States.
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