Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049 Recalled by Iris Diagnostics Due to Iris International is recalling the iChemVELOCITY systems because...
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 Iris Diagnostics directly.
Affected Products
iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips.
Quantity: 2,448 units
Why Was This Recalled?
Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-board strip stability claim of 5 days at 18-28 degrees celsius at 20-80% relative humidity (RH) as stated in the iChemVELOCITY product labeling.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Iris Diagnostics
Iris Diagnostics has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report