Copan WASP
Brescia Lombardy, IT
Copan WASP appears in FDA device records in Brescia Lombardy, IT. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Copan WASP between 2021 and 2026. The busiest year on record is 2023, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251511 | PhenoMATRIX | PPU | Substantially Equivalent | |
| K232756 | Colibrí | LON | Substantially Equivalent | |
| K223245 | Colibrí | QQV | Substantially Equivalent | |
| K220546 | Colibrí System | LON | Substantially Equivalent | |
| K193138 | Colibri System | QQV | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009288740 | 3009288740 | Copan WASP | Via Achille Grandi, 32, Brescia Lombardy 25125 IT | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KZBAutomated Colony Counter
- QQVAutomated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
- JTQBath, Incubators/Water, All
- JQPCalculator/Data Processing Module, For Clinical Use
- QQYCulture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
- JCBDetergent
- JTCDevice, Microtiter Diluting/Dispensing
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- FRLFiber, Medical, Absorbent
- QBNMass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
- PPUMicrobial Colony Image Assessment System
- KEWSlides, Microscope
- JQWStation, Pipetting And Diluting, For Clinical Use
- LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2854-2026 | 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 Description: WASPLab is an automated device intended to be used for the incubation and the digital imaging of agar culture plates streaked with microbiological specimens derived by the human body for microbiological investigations. WebApp software is the user interface of WASPLab device. | Due to a software issue within the WebApp that potentially prevents the user to overwrite the results. | Class II | Open, Classified | |
| Z-1812-2025 | PhenoMATRIX | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain