Alinity i Anti-TPO Reagent Kit, List Number 09P3521
- Recall Initiated
- April 24, 2023
- Posted
- June 8, 2023
- Recall Number
- Z-1696-2023
- Quantity
- 110 kits
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
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 / Code Info
UDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024
Root Cause
Nonconforming Material/Component
Action Taken
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.