FDAFDA · Food and drugs·Recall number Z-1696-2023
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Published June 14, 2023 · Recall initiated: April 24, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Ireland Limited
- Distributor
- 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.
- Lot
- UDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- Ireland
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