FDA recall record

WASPLab recall — FDA Z-2854-2026

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

Class IIclassification
Z-2854-2026official record ID
Aug 12, 2026report date

Recall record at a glance

Official recordZ-2854-2026
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmCopan WASP
Report dateAug 12, 2026
Recall initiation dateJun 16, 2026
Quantity1
LocationBrescia, Italy

Official product description

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.

Why the product was recalled

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

Distribution information

US Nationwide distribution in the state of Arizona.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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