Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Alinity i Anti-TPO Reagent Kit Recalled by Abbott Ireland Limited Due to Due to a manufacturing fill volume error, Alinity...
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 Abbott Ireland Limited directly.
Affected Products
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Quantity: 110 kits
Why Was This Recalled?
Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Abbott Ireland Limited
Abbott Ireland Limited has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report