Phadia 2500EE Instrument Recall: Higher Gliadin Test Results
Phadia US Inc recalls 2500EE instruments that may show higher results for gliadin tests than the 2500 instrument. Affected units have specific serial numbers and were sold for celiac disease testing.
Lower-risk 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
Contact the company
What happened, in plain English
Phadia US Inc is recalling its 2500EE laboratory instruments because they may produce higher test results for gliadin antibodies than the 2500 model. This could lead to inaccurate celiac disease diagnoses if used improperly. Read more at govinfonow.com/recall/58487-phadia-2500ee-instrument-recall-higher-gliadin-test-results.
Source Summary by GovInfoNow · govinfonow.com/recall/58487-phadia-2500ee-instrument-recall-higher-gliadin-test-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2041-2023
Cite this page
“Phadia 2500EE Instrument Recall: Higher Gliadin Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58487-phadia-2500ee-instrument-recall-higher-gliadin-test-results. Based on FDA recall #Z-2041-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2041-2023%22&limit=1).
Why it’s dangerous
The 2500EE instrument may report higher levels of gliadin antibodies than the 2500 model when running the same test. This difference could cause false positives in celiac disease diagnosis if not corrected.
Who’s affected
Lab users who own or operate the Phadia 2500EE instrument for celiac disease testing are affected. Those testing for gliadin antibodies may be at risk of inaccurate results.
How to tell if you have this one
Check your Phadia 2500EE instrument's serial number. The product was sold for celiac disease testing and has a specific material number (12410002) and UDI (07333066020938).
- Brand
Phadia- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US: CA, NJ, MI
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2040-2023 | 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; UDI: 07333066010847 All lots | 568 units US |
| Z-2041-2023 | 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; UDI: 07333066020938 All Serial Numbers | 9 units |
What to do — step by step
Check Serial Number
Identify your Phadia 2500EE instrument's serial number to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “US: CA, NJ, MI” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Michigan, New Jersey.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2041-2023 (May 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2041-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.