Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Iris Diagnostics Division iQ Control/Focus Set Recalled by Iris Diagnostics Due to The firm initiated this recall because complaints from...
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
Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.
Quantity: 942 boxes
Why Was This Recalled?
The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. This results in the instrument not passing controls and the customer not being able to run patient samples.
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