Z-2854-2026Class II

Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1...

Name: Z-2854-2026 Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1...
Creator: Copan WASP
Published: 2026-06-16
License: https://open.fda.gov/license/

Copan WASP / initiated 2026-06-16 / Open, Classified / root cause: software

FDA source

Copan WASP began a recall of 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... on 2026-06-16. FDA classified it as Class II and gives the reason as "Due to a software issue within the WebApp that potentially prevents the user to overwrite the results". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2854-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-16
Posted: 2026-07-31
Recalling firm: Copan WASP
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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: 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 [email protected]
Quantity in commerce: 1
Distribution: US Nationwide distribution in the state of Arizona.
Product codes and lots: Lot Code: WebApp version 2.33.1, 2.33.3 and 2.34.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2854-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2854-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-07-31

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)