Abbott Ireland Limited 2023-06-14 Health moderate FDA
Health · FDA · Recall #FDA-Z-1696-2023
Alinity i Anti-TPO Reagent Kit, List Number 09P3521 Recall
Issued June 14, 2023 · Abbott Ireland Limited
In June 2023, Abbott Ireland Limited recalled the Alinity i Anti-TPO Reagent Kit, List Number 09P3521, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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).
What you should do
- 1 Stop using Alinity i Anti-TPO Reagent Kit, List Number 09P3521 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Abbott Ireland Limited to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Abbott Ireland Limited
- Category
- Health
- Recall date
- June 14, 2023
- Units affected
- Not reported
- 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 di
- Recall number
- FDA-Z-1696-2023
- Made in
- Ireland
- Issuing agency
- FDA
In context
- Abbott Ireland Limited has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.