Brescia, N/A, Italy
Copan WASP recalls
2 recalls recorded since 2018, most recently on 16 June 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 June 2026
- Reason
- Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.
- Distribution
- US Nationwide distribution in the state of Arizona.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 incubati
Ongoing Class II Medical devices
- Recall started
- 6 May 2025
- 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.
- Distribution
- US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1812-2025
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.