Z-1696-2023 Class III Ongoing
FDA device recall Z-1696-2023 was initiated by Abbott Ireland Limited on April 24, 2023 and is designated Class III. Reason for recall: 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). The recall status is ongoing. Affected quantity: 110 kits.
Recall Details
- Product Type
- Devices
- Report Date
- June 14, 2023
- Initiation Date
- April 24, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 110 kits
Product Description
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Reason for Recall
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 Pattern
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.
Code Information
UDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024