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EliA GliadinDP IgG Well in the Phadia 2500EE instrument… recallZ-2040-2023 · Phadia US Inc · initiated May 1, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Phadia US Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-2040-2023
Status
Open, Classified
Initiated by the company
May 1, 2023
Posted by the FDA
Jun 30, 2023
Recalling firm
Phadia US Inc
Quantity
568 units US
Product code
MST
FDA submissions
K093459
Distribution
US: CA, NJ, MI

Product description

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

Code information (models, lots, serial numbers)

UDI: 07333066010847 All lots

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 92365).

Sources and updates

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