Abbott Ireland Limited recalls Alinity i Anti-TPO Reagent Kit, List Number 09P3521

Recall date

April 24, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1696-2023

FDA classification

Class III

Brand / firm

Abbott Ireland Limited

Sold / distributed

US Nationwide distribution in the states of CA, CO, FL, GA, IL, KY, LA, MD, MI, MN, NJ, NY, OH, RI, SC, SD, TN, TX, WA. No international distribution of affected lot.

Why it was 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).

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Alinity i Anti-TPO Reagent Kit, List Number 09P3521