Iris Diagnostics Recalls Urine Chemistry Control Material Due to Inaccurate Results
Iris Diagnostics is recalling IRISpec CA/CB urine chemistry control material because nitrite results were incorrectly negative.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a quality control material failure rather than a direct patient safety hazard.
Plain-English summary
Iris Diagnostics is recalling 862 units of IRISpec CA/CB two-part urine chemistry control twin sets, part number 800-0074, lot number 131-12. The product is an assayed quality control material intended for in vitro diagnostic use to monitor urine chemistry analytes and devices.
The recall was initiated after the firm received complaints that the nitrite results for the part B control read negative, whereas they should have read positive. This indicates a potential failure in the quality control material's ability to accurately monitor the intended analytes.
The affected product was distributed nationwide. Users of this product should stop using the recalled control material and contact Iris Diagnostics for further instructions or a replacement.
The recalled product
- Product
- IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD)…
- Manufacturer
- Iris Diagnostics
- Hazard
- Affected units
- 862
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 (2)
- Iris Diagnostics part number 800-0074
- lot number 131-12.
Distribution
Distributed nationwide across the United States.
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