# FDA recall Z-1696-2023

> **Abbott Ireland Limited** · Class III · device recall initiated 2023-04-24.

## 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

- **Recall number:** Z-1696-2023
- **Recalling firm:** Abbott Ireland Limited
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-24
- **Report date:** 2023-06-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sligo, Ireland

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1696-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1696-2023. Source: US FDA. Licensed CC0.

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