Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Recalled by Omnyx Llc Due to There is an issue associated with Digital Pathology...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Omnyx Llc directly.
Affected Products
Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for digital whole slide images. Omnyx" products are for in vitro diagnostic use for specific clinical applications, and are intended for research use only on other applications. Specific clinical use applications are indicated in separate clinical specific user guides supplied by Omnyx.
Quantity: 2
Why Was This Recalled?
There is an issue associated with Digital Pathology System (DPS) Software, in which the annotation tools within the DPS version 1.1 Image Viewer will display incorrect measurements and area calculations for a region of interest on a scanned slide, under certain conditions.
Where Was This Sold?
International Distribution to Canada and Switzerland only.
About Omnyx Llc
Omnyx Llc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report