Sligo, Ireland
Abbott Ireland Limited recalls
1 recall recorded since 2018, most recently on 24 April 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class III Medical devices
- Recall started
- 24 April 2023
- Reason
- 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).
- Distribution
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1696-2023
- Alinity i Anti-TPO Reagent Kit, List Number 09P3521
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.