Copan WASP: Medical Device Recall in 2025 - (Recall #: Z-1812-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

PhenoMATRIX

Product Classification:

Class II

Date Initiated: May 6, 2025

Date Posted: May 28, 2025

Recall Number: Z-1812-2025

Event ID: 96765

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.

Status: Ongoing

Product Quantity: 14

Code Information:

All software versions

Distribution Pattern:

US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV.

Voluntary or Mandated:

Voluntary: Firm initiated