Recall Z-2854-2026
Copan WASP · initiated June 16, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot Code: WebApp version 2.33.1, 2.33.3 and 2.34.2
Reason for recall
Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.
FDA-determined cause: Under Investigation by firm
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
Details
- Recall number
- Z-2854-2026
- Initiated
- June 16, 2026
- Posted by FDA
- July 31, 2026
- Product code
- JQP – Calculator/Data Processing Module, For Clinical Use
- Quantity
- 1
- Distribution
- US Nationwide distribution in the state of Arizona.
- Recalling firm
- Copan WASP, Brescia