FDAMay 6, 2025device
PhenoMATRIX
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
copan waspcopan
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDA1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System2025-10-29
- FDA1ml of DTT in liquid phase, in PET tube with capture cap, in bulk2025-10-29
- FDABD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only2025-05-02
- FDACOPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.2023-07-14
- FDACOPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm; REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Single Wrapped, bp 60MM, BUNDLES OF 20 pcs; REF: 501CS01.Q20, P/N 1127700, Minitip Ap...2021-07-09
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