Z-1812-2025Class II

PhenoMATRIX

Name: Z-1812-2025 PhenoMATRIX
Creator: Copan WASP
Published: 2025-05-06
License: https://open.fda.gov/license/

Copan WASP / initiated 2025-05-06 / Open, Classified / root cause: software

FDA source

Copan WASP began a recall of PhenoMATRIX on 2025-05-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1812-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-06
Posted: 2025-05-21
Recalling firm: Copan WASP
Product: PhenoMATRIX
Product code: KZB Automated Colony Counter
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.
Root cause tag: software
FDA root cause: No Marketing Application
Action: On 5/6/2025, recall notices were mailed to customers informing them of the following: Ensure the plate images are reviewed against the actual agar plate to verify the assessment you performed by the digital image inspection. Complete and return the response form via email to [email protected]
Quantity in commerce: 14
Distribution: US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV.
Product codes and lots: All software versions

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1812-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1812-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-28	2025-05-21

Product code KZB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)