PhenoMATRIX
Reported: May 28, 2025 Initiated: May 6, 2025 #Z-1812-2025
Product Description
PhenoMATRIX
Reason for Recall
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.
Details
- Recalling Firm
- Copan WASP
- Units Affected
- 14
- Distribution
- US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV.
- Location
- Brescia, N/A
Frequently Asked Questions
What product was recalled? ▼
PhenoMATRIX. Recalled by Copan WASP. Units affected: 14.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 28, 2025. Severity: Moderate. Recall number: Z-1812-2025.
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