Iris Diagnostics Recalls iChemVELOCITY Urine Chemistry Systems for Labeling Error
Iris Diagnostics is recalling iChemVELOCITY Automated Urine Chemistry systems because they do not maintain the claimed 5-day strip stability under specified conditions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding strip stability. Per the rubric, minor labeling errors and low-risk issues without reported injuries or illnesses fall under the Moderate severity category.
Plain-English summary
Iris Diagnostics is recalling the iChemVELOCITY Automated Urine Chemistry systems, including catalog numbers 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7719, and 800-7720. The recall involves 2,448 units distributed worldwide, including the United States (nationwide and Puerto Rico) and numerous international locations.
The recall was initiated because the devices do not maintain the on-board strip stability claim of 5 days at 18-28 degrees Celsius at 20-80% relative humidity, as stated in the product labeling. This discrepancy between the actual performance and the labeled claim constitutes a labeling error.
Healthcare facilities and users of these in vitro diagnostic devices should stop using the affected units and contact Iris Diagnostics for further instructions. The recall covers all serial numbers of the specified catalog numbers.
The recalled product
- Product
- 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…
- Manufacturer
- Iris Diagnostics
- Hazard
- Affected units
- 2,448
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial Numbers
Distribution
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