Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Alinity i Ferritin Reagent Kit Recalled by Abbott Ireland Diagnostics Division Due to Abbott has become aware of a manufacturing issue...
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 Diagnostics Division directly.
Affected Products
Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.
Quantity: 216 units
Why Was This Recalled?
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
Where Was This Sold?
This product was distributed to 6 states: AR, FL, GA, MD, OK, VA
About Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report