Class II — Potential Health Hazard

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...

Date: November 21, 2018
Company: Abbott Ireland Diagnostics Division
Status: Terminated
Source: FDA (Device)

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

Affected (6 states)Not affected

About Abbott Ireland Diagnostics Division

Abbott Ireland Diagnostics Division has 12 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report