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Abbott Ireland Limited recalls Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Recalled June 14, 2023 · FDA recall Z-1696-2023 · Abbott Ireland
Hazard
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). · FDA Class III
Units
110 kits
Sold at
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.
Description
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).
Product
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Manufacturer(s)
Abbott Ireland Limited
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →