CLASS II ONGOING Device recall · Reported 28 May 2025 · FDA Enforcement Report
PhenoMATRIX recalled by Copan WASP
Copan Wasp is recalling PhenoMATRIX, distributed nationwide in the US. The recall was initiated on 6 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1812-2025
- FDA event ID
- 96765
- Recalling firm
- Copan Wasp, Brescia, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 May 2025
- FDA classified
- 21 May 2025
- Reported
- 28 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 6 May 2025 | Recall initiated by company | |
| 21 May 2025 | Classified by FDA | +15 days |
| 28 May 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
PhenoMATRIX
Where it was distributed
US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV.
Nationwide ArkansasCaliforniaIllinoisKansasMassachusettsMarylandNorth CarolinaNew JerseyNevadaNew YorkPennsylvaniaTexasUtah
Questions about this recall
Why was it 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 lots are affected?
All software versions
Where was it sold?
US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Copan Wasp
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 recalled | Copan Wasp | Device Malfunction | Nationwide |
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