FDA recall Z-1696-2023

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2023-04-24

Report date

2023-06-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sligo, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1696-2023