Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CARA (Computer Assisted Retinal Analysis) Recalled by Diagnos Inc Due to Retinal analysis system software has some features, based...
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 Diagnos Inc directly.
Affected Products
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Quantity: 1
Why Was This Recalled?
Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version.
Where Was This Sold?
This product was distributed to 1 state: CA
About Diagnos Inc
Diagnos Inc 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