DeviceSignal · Recall classified

Copan WASP

FDA classified a device recall on 2026-07-31 · Class II · Z-2854-2026

EventRecall classified
Effective2026-07-31
ClassificationClass II

On 2026-07-31 the FDA classified a device recall from Copan WASP as Class II. Product: Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version…. Recall Z-2854-2026. The firm initiated it on 2026-06-16. This reports the classification FDA published on that date.

Reported facts

Recall number
Z-2854-2026
Classification
Class II
Classified on
2026-07-31
Initiated on
2026-06-16
Firm
Copan WASP
Reason
Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.
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.

Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.

Provenance

Source
fda_device_enforcement
Source record
Z-2854-2026
Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72
Source URL
https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
Observed
2026-09-08T16:22:09.483Z
Transform
fda_device_enforcement_to_recall v1
Event rule
fda_device_recall_classified v1
Event key
8d0738545ea9740657a68dcd33b7a85fdbcec08ce7834e82ef0439322767cb26
Signal type
device_recall.classified

Source terms that apply

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Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)