Reported May 28, 2025 · Ongoing
PhenoMATRIX
Copan WASP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Copan WASP · Via Achille Grandi, 32 · Brescia, N/A · N/A
Is this the product you have?
- PhenoMATRIX
- Lot codes and dates
- All software versions
- Amount recalled
- 14
Where it was sold
Why it was recalled
AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and may lead to inaccurate counts and/or morphology characteristics impacting patient diagnosis and subsequent care.
This product could cause temporary or reversible health problems — stop using it.
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