Bacterial Culture Analysis Software Lacks Required FDA Premarket Approval
PhenoMATRIX, an AI-powered bacterial culture interpretation software by Copan WASP, has been recalled because it lacks FDA premarket approval and may provide inaccurate bacterial analysis results.
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: This is an FDA Class II recall for a diagnostic software system that lacks required premarket approval and may provide inaccurate results affecting patient diagnosis and care. However, no illnesses, injuries, or incidents have been reported, making the hazard theoretical.
Plain-English summary
PhenoMATRIX is an AI-powered software system used to interpret bacterial culture plates and provide analysis of colony counts and bacterial morphology. The software is manufactured by Copan WASP and has been distributed nationwide to clinical laboratories in multiple U.S. states.
The FDA has initiated a Class II recall because PhenoMATRIX lacks the required Premarket Approval or premarket notification (510(k) or de novo clearance). Without this regulatory approval, there is a potential risk that the colony count and/or morphology information provided by the software may not accurately reflect the actual culture plate, which could lead to inaccurate bacterial identification and subsequent errors in patient diagnosis and care.
This recall affects all versions of PhenoMATRIX software distributed to clinical laboratories and healthcare facilities in Utah, Arkansas, California, Pennsylvania, Maryland, North Carolina, Illinois, Massachusetts, New Jersey, Kansas, Texas, New York, and Nevada.
The recalled product
- Product
- PhenoMATRIX
- Manufacturer
- Copan WASP
- Hazard
- diagnostic-error
- inaccurate-results
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 software versions
Distribution
Distributed nationwide across the United States.
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