---
title: "Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measure... — FDA record Z-2041-2023 | Is It on Recall"
description: "Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrume"
url: https://isitonrecall.com/recall/fda-device-z-2041-2023-phadia-2500ee-instrument-intended-for-the-in-vitro-semi-quantitative-measurement-of-igg-antibodies-d/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliad... — FDA record Z-2041-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 1, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Phadia 2500EE instrument -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 12410002
- **Reason**: 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
- **Classification**: Class II
- **Recalling firm**: Phadia US Inc
- **Quantity**: 9 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2041-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2041-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI: 07333066020938 All Serial Numbers |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US: CA, NJ, MI

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)

## Dates in the source

- **Report date**: Jul 5, 2023
- **Recall initiation date**: May 1, 2023
- **Center classification date**: Jun 29, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2041-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Phadia US Inc records](https://isitonrecall.com/brand/phadia-us-inc/)