UnratedMedical device recall · FDA · Published May 6, 2025
Copan WASP PhenoMATRIX Software Recall: Potential Inaccurate Patient Diagnosis
Copan WAS: PhenoMATRIX software lacks pre-market approval, risking inaccurate bacterial culture results that could affect patient diagnosis and treatment. Affected users should contact for details.
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.
“Copan WASP PhenoMATRIX Software Recall: Potential Inaccurate Patient Diagnosis.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52337-copan-wasp-phenomatrix-software-recall-potential-inaccurate-patient-diagnosis. Based on FDA recall #Z-1812-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1812-2025%22&limit=1).
The FDA announced on May 6, 2025, that Copan WASP is recalling PhenoMATRIX software due to the lack of required premarket approval. This unapproved status creates a potential risk of inaccurate colony count and morphology data. The agency classified the recall as Class II.
How to tell if you have it
Brand: Copan WASP
Product: PhenoMATRIX
Version: All software versions
The hazard
The AI-powered bacterial culture plate interpretation and workup software lacks Premarket Approval or pre-market notification. This absence poses a potential risk that colony count and/or morphology information from images may not accurately reflect the actual plate. Such inaccuracies could impact patient diagnosis and subsequent care.
Context
GovInfoNow's records show Copan WASP has one other recall on record since June 16, 2026, involving WASPLab W087 Software Version 2.33.1/2.33.3/2.34.2. Other recent recalls of similar products include Copan Italia DTT Liquid Reagent Recall (Oct. 29, 2025), Siemens SOMATOM X.ceed Software Applications Recall (Dec. 19, 2025), and Siemens CT Software Apps: Unapproved Medical Software Recalled (Dec. 19, 2025).
How to tell if you have this one
Check if you own PhenoMATRIX software for bacterial culture analysis. All versions are affected, but the specific software name is PhenoMATRIX.
Brand
Copan WASP
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to Copan WASP directly for instructions on how to handle the software.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 13 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, California, Illinois, Kansas, Maryland, Massachusetts, Nevada, New Jersey, New York, North Carolina, Pennsylvania, Texas, Utah.
Recall timeline
FDA published this recall 22 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1812-2025 (May 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1812-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.