Copan WASP FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3 Class IIJun 16, 2026Due to a software issue within the WebApp that potentially p	Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.	Class IIDevices	Jun 16, 2026
PhenoMATRIXClass IIMay 6, 2025AI-powered bacterial culture plate interpretation and workup	AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-	Class IIDevices	May 6, 2025