Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
IRISpec" CA/CB two-part urine chemistry control twin set Recalled by Iris Diagnostics Due to The firm recalled after it received complaints of...
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
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) use only.
Quantity: 862
Why Was This Recalled?
The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control, 101131-12, where the nitrite results read negative for the part B control, which should be positive.
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