Recall Z-1812-2025 ยท KZB Automated Colony Counter
Copan WASP
PhenoMATRIX
| Date | May 21, 2025 (initiated May 6, 2025) |
| Status | Open, Classified |
| Reason | 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 | 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 regulatory.wasp@copangroup.com |
| Quantity | 14 |
| Distribution | US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.