Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ItalyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Copan WASP Srl with 5 510(k) clearances, 2 device recalls and 1 AI-enabled device. The most recent is a device recall dated Jun 16, 2026: Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 16, 2026 | Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3 and 2.34.2 Product Class II · Due to a software issue within the WebApp that potentially prevents the user to overwrite the results. | Device recalls |
| Jan 22, 2026 | PhenoMATRIXK251511 · PPU | 510(k) clearances |
| Jan 22, 2026 | PhenoMATRIXK251511 · Microbiology | AI-enabled devices |
| May 6, 2025 | PhenoMATRIXClass II · AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market not | Device recalls |
| Dec 27, 2023 | ColibríK232756 · LON | 510(k) clearances |
| Mar 20, 2023 | ColibríK223245 · QQV | 510(k) clearances |
| Oct 5, 2022 | Colibrí SystemK220546 · LON | 510(k) clearances |
| Dec 27, 2021 | Colibri SystemK193138 · QQV | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
