Z-2040-2023Class II

EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is...

Name: Z-2040-2023 EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is...
Creator: Phadia US Inc
Published: 2023-05-01
License: https://open.fda.gov/license/

Phadia AB / initiated 2023-05-01 / Open, Classified

FDA source

Phadia US Inc began a recall of EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for the in vitro semi-quantitative... on 2023-05-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2040-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-01
Posted: 2023-06-30
Recalling firm: Phadia AB
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
Product code: MST Antibodies, Gliadin
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
FDA root cause: Under Investigation by firm
Action: Themofisher Scientific/Phadia US issued Urgent Medical Device Recall Letter-Medical Device Field Safety Notice issued May 1, 2023. Letter states reason for recall, health risk and action to take: d13 EliA U/mL (due to risk of false positive EliA GliadinDP IgG results in this range) according to your internal procedures. Log files may only be available for analysis for a limited timeframe on the Phadia Laboratory System due to storage and maintenance restrictions and may not cover the entire timeframe of the Instrument message log. " As noted above in section 1.3, also review test results for Total IgA and EliA Celikey IgA (if tested) to identify potential IgA deficient patients. " Should you need help, contact Phadia US Technical Support who can further assist in collecting log files and aid in identifying the potentially impacted test results. 2) Use of the EliA GliadinDP IgG Well on Phadia 2500EE can continue as detailed in the user manual and the DfU with the following recommendations: " For EliA GliadinDP IgG results that fall in the range of e10 to d13 EliA U/mL (due to risk of false positive EliA GliadinDP IgG results) and are IgA deficient: a. Verify positive EliA GliadinDP IgG results using a Phadia 250 instrument if available. Use the result generated on the Phadia 250 to report patient results in line with the user manual and DfU. b. As another option, you may wish to verify positive EliA GliadinDP IgG results by running EliA Celikey IgG on your existing, Phadia 2500EE. It is important to note that EliA Celikey IgG is not a direct alternative for EliA GliadinDP IgG and results generated are not readily interchangeable. Both EliA tests are designed to assist in the diagnosis of celiac disease. Further scientific background on this recommendation can be provided by Phadia s US Technical Support team. c. If you do not have direct access to a Phadia 250 instrument in your laboratory or utilize EliA Celikey IgG, please contact Phadia s US Technical Suppor
Quantity in commerce: 568 units US
Distribution: US: CA, NJ, MI
Product codes and lots: UDI: 07333066010847 All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2040-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2040-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-29
Z-2041-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-29

Product code MST

K093459Class IIElia Gliadin Dp Iga Immunoassay and Elia Gliadin Dp Igg Immunoassay, Models 14-5538-01, 14-5539-01Phadia US, Inc. / cleared 2010-08-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)