FDA-Device2023-06-14Class III
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Abbott Ireland Limited
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).
Sold states
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.
Affected count
110 kits
Manufactured in
Finisklin Business & Technology Park, Sligo, Ireland
Products
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1696-2023Don't want to check this manually?
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