Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3 and

FDA device recall Z-2854-2026 · posted 2026-07-31 · Open, Classified

Recall details

Recalling firm

Copan WASP

Reason for recall

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

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JQP

Quantity affected

1

Distribution

US Nationwide distribution in the state of Arizona.

Date initiated

2026-06-16

Date posted

2026-07-31

Location

Brescia, Italy