Summary
The FDA issued a Class II for PhenoMATRIX by Copan WASP. Reason: AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so.
Details
Source
Device Recall
External ID
Z-1812-2025
Action Date
2025-05-28
Status
Ongoing
Category
device
Product Description
PhenoMATRIX
Lot/Code Info: All software versions
Quantity Affected: 14
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.
Distribution
US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-06
Company
Brescia, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Copan WASP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Copan WASP have FDA actions?
This is the only FDA action we have on record for Copan WASP in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1812-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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