FDA recall: Copan's AI culture-plate reader PhenoMATRIX used in US labs without clearance, risking inaccurate colony counts
What happenedOn May 6, 2025, Copan WASP began a Class 2 recall (Z-1812-2025) of PhenoMATRIX. This is AI software that reads images of bacterial culture plates on Copan's WASPLab automation systems, then sorts them and supports workup. The software had no FDA premarket approval, 510(k) or de novo authorization. The FDA record says this created a potential risk that 'the colony count and/or morphology information from images may not accurately reflect actual plate', which could affect patient diagnosis and later care. Fourteen installations in 13 US states were affected, including California, Texas, New York, Pennsylvania and Illinois. Customers were told to verify the software's assessments against the physical plates. No patient harm was reported. Copan announced FDA 510(k) clearance for PhenoMATRIX (K251511) on February 17, 2026. Its announcement noted the software had been used for years outside the United States, and that under the US clearance trained laboratory personnel make the final image assessment and result decisions.
Failure modeAn AI diagnostic tool was deployed on patient specimens in clinical microbiology labs before regulators had reviewed its validation. Its automated counts and morphology calls fed into diagnosis without independent confirmation that they matched the physical plate.
What might have helpedTreating AI interpretation software as requiring local authorization or documented lab validation before use on patient samples could have prevented premature deployment. Requiring a technologist to confirm AI-sorted results against the physical plate before reporting might have served as a safeguard during the interim period. Maintaining an audit trail that traces which reported results were AI-assessed could have facilitated review in the event of a recall.
Fix adopted Since thenCopan announced FDA 510(k) clearance (K251511) for PhenoMATRIX on February 17, 2026, bringing the software under FDA authorisation. The cleared US use leaves final image assessment and result decisions to trained laboratory personnel.
Still openClearance came after the software had already been installed in US labs without authorisation. The recall did not report patient-level error rates, and the public record does not show how long the US installations ran before the recall.
LessonAuthorisation came after the fact, and patient samples in US labs were read by unauthorised AI before the recall. Checking regulatory status before go-live, rather than after a recall, would have closed that gap.
Sources: prnewswire.com · accessdata.fda.gov
Updates: 2026-09-30: The recall facts still hold (Z-1812-2025, 14 units, 13 states, still open). The 510(k) announcement (K251511, 17 February 2026) says the years of prior use were outside the United States, and the cleared US use leaves final assessment to trained laboratory staff. The current wording implies years of unauthorised US use, which the sources do not establish.