Abbott Ireland Limited Finisklin Business & Technology Park Sligo Ireland Alinity i Anti-TPO Reagent Kit, List Number 09P3521 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Brand
Abbott Ireland Limited Finisklin Business & Technology Park Sligo Ireland
Lot Codes / Batch Numbers
UDI Number: (01)00380740153892(17)240720(10)46009FN00, List Number: 09P3521, Lot Number: 46009FN00, Expiration Date: 07/20/2024
Products Sold
UDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024
Abbott Ireland Limited Finisklin Business & Technology Park Sligo Ireland is recalling Alinity i Anti-TPO Reagent Kit, List Number 09P3521 due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
On April 24, 2023, Abbott issued a Product Correction letter, via FedEx priority overnight express, for this issue. Customers were instructed to provide a copy of the Product Correction letter to the laboratory manager, supervisor or health professional responsible for the impacted product and to complete and return the Customer Reply form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026