Recall Z-1696-2023
Abbott Ireland Limited · initiated April 24, 2023
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Codes / lots: UDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024
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).
FDA-determined 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.
Details
- Recall number
- Z-1696-2023
- Initiated
- April 24, 2023
- Posted by FDA
- June 8, 2023
- Product code
- JZO – System, Test, Thyroid Autoantibody
- Quantity
- 110 kits
- 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.
- Recalling firm
- Abbott Ireland Limited, Sligo