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's PhenoMATRIX software, used for interpreting bacterial cultures, has been recalled because it hasn't been approved by the FDA before being sold. This could lead to incorrect patient diagnoses and treatments if the software misreads colony counts or shapes.
The software lacks FDA pre-market approval, meaning it hasn't been tested to ensure accurate colony counts and shapes. This could cause misdiagnosis by showing incorrect bacterial patterns, leading to improper patient care.
Healthcare professionals using PhenoMATRIX software for bacterial culture analysis are most at risk, as inaccurate results could lead to wrong patient treatments.
Check if you own PhenoMATRIX software for bacterial culture analysis. All versions are affected, but the specific software name is PhenoMATRIX.
Reach out to Copan WASP directly for instructions on how to handle the software.
The recall record states the software lacks FDA pre-market approval, so it may not be safe for accurate patient diagnosis.
Check if you own PhenoMATRIX software for bacterial culture analysis; all versions are affected.
The recall record does not specify a remedy, so contact Copan WASP directly for instructions.
We’ve drafted a message you can send Copan WASP to request your refund or repair — edit it as you like.
Subject: Recall Z-1812-2025 — Copan WASP Copan WASP Hello, I own a Copan WASP that is covered by recall Z-1812-2025 from Copan WASP. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
