Abbott Ireland Limited: Medical Device Recall in 2023 - (Recall #: Z-1696-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Alinity i Anti-TPO Reagent Kit, List Number 09P3521

Product Classification:

Class III

Date Initiated: April 24, 2023

Date Posted: June 14, 2023

Recall Number: Z-1696-2023

Event ID: 92271

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).

Status: Ongoing

Product Quantity: 110 kits

Code Information:

UDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024

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.

Voluntary or Mandated:

Voluntary: Firm initiated