Copan WASP

FDA Regulatory Profile

Copan WASP appears in FDA public data with 2 recalls, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2854-2026, Class II) was initiated on June 16, 2026. Its most recent 510(k) clearance was granted on January 22, 2026.

Summary

Total Recalls
2
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2854-2026Class IIBrand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp verJune 16, 2026
Z-1812-2025Class IIPhenoMATRIXMay 6, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K251511PhenoMATRIXJanuary 22, 2026
K232756ColibríDecember 27, 2023
K223245ColibríMarch 20, 2023
K220546Colibrí SystemOctober 5, 2022
K193138Colibri SystemDecember 27, 2021