# FDA recall Z-2040-2023

> **Phadia US Inc** · Class II · device recall initiated 2023-05-01.

## Product

EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002)  EliA GliadinDP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease  Material Number	14553901

## Reason for recall

Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument

## Distribution

US: CA, NJ, MI

## Key facts

- **Recall number:** Z-2040-2023
- **Recalling firm:** Phadia US Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-01
- **Report date:** 2023-07-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Portage, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2040-2023

## Citation

> AI Analytics. FDA recall Z-2040-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2040-2023. Source: US FDA. Licensed CC0.

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