PhenoMATRIX recall: Software Issue
PhenoMATRIX
Why was PhenoMATRIX 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All software versions
- Product
- PhenoMATRIX
- Recalling firm
- Copan WASP
- Quantity
- 14
- Distribution
- US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV.
- Recall date
- May 28, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)