Abbott Ireland Limited: Alinity i Anti-TPO Reagent Kit, List Number 09P3521

Hazard

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).

Details from the source

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. Quantity: 110 kits Lot/code info: UDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024

UPC codes

00380740153892

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.