Copan WASP recalls Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Versio…

Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.

On 06/16/2026, an "URGENT MEDICAL DEVICE RECALL" Letter was provided to customers informing them that, A software bug has been identified in the WebApp software which, under specific conditions, may prevent the result suggested by PhenoMATRIX from being overwritten by the result selected by the user. As a consequence, the result transmitted by WASPLab to the LIS may be the result suggested by PhenoMATRIX, rather than the result selected by the user. Customers were informed and instructed: In date 2026/06/15 we released a WebApp software version including the bugfix of this issue. As a consequence, you are required to schedule with your distributor the software update to correct the issue and, in the meanwhile, to check the results sent to LIS in case you changed the result suggested by PhenoMATRIX. Complete the attached Customer Response Form and return to the Copan WASP Srl contact noted on the form so that Copan WASP Srl may acknowledge your receipt of this notification. For questions or further assistance email regulatory.wasp@copangroup.com

• FDA enforcement recordOfficial FDA database entry for Z-2854-2026
• FDA device classification · JQPOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.2100The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Copan WASPSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.