PhenoMATRIX bacterial culture plate interpretation software recalled nationwide
Copan WASP is recalling PhenoMATRIX, an AI-powered bacterial culture plate interpretation software, because it lacks required FDA premarket approval, creating potential risk of inaccurate colony counts and morphology data that could affect patient diagnosis.
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: This is an FDA Class II medical device recall. The hazard involves risk of harm to patient diagnosis through inaccurate microbiology results, and the source text explicitly states no illnesses or injuries have been reported. Class II recalls with no reported adverse events but significant risk of patient harm typically score as High (3).
Plain-English summary
Copan WASP is recalling all versions of PhenoMATRIX, AI-powered software designed to interpret bacterial culture plates and guide workup procedures. The software does not have FDA Premarket Approval or premarket notification (510(k) or de novo clearance) as required by law.
Without the required premarket review, there is potential risk that the colony count and morphology information generated from the software's image analysis may not accurately reflect the actual culture plate. This could result in inaccurate counts and morphology characteristics that impact patient diagnosis and subsequent care.
The recall affects PhenoMATRIX distributed nationwide across the following states: Utah, Arkansas, California, Pennsylvania, Maryland, North Carolina, Illinois, Massachusetts, New Jersey, Kansas, Texas, New York, and Nevada.
Laboratories and healthcare facilities currently using PhenoMATRIX should contact Copan WASP for instructions regarding the recall.
The recalled product
- Product
- PhenoMATRIX
- Manufacturer
- Copan WASP
- Affected units
- 14
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
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