FDA Enforcement
Class III
Ongoing
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Recall: Z-1696-2023
·
Reported June 14, 2023
Enforcement
- Recall Number
- Z-1696-2023
- Event ID
- 92271
- Classification
- Class III
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Abbott Ireland Limited
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 14, 2023
- Initiation Date
- April 24, 2023
- Classification Date
- June 8, 2023
- Address
- Finisklin Business & Technology Park, Sligo, N/A, Ireland
Description
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
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).
Code Info
UDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024
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.
Quantity
110 kits