Diagnostic Test Well Shows Inconsistent Results on Phadia 2500EE
The EliA GliadinDP IgG test well produces higher reported results when used on the Phadia 2500EE instrument compared to the Phadia 250, potentially causing diagnostic inaccuracies. Phadia US Inc is recalling 568 units distributed in California, New Jersey, and Michigan.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II medical device recall for an analytical accuracy issue with no reported illnesses or adverse events. The test produces higher results on one instrument than another, representing a quality concern and potential for diagnostic error but lacking reported patient harm.
Plain-English summary
The EliA GliadinDP IgG test well is a diagnostic test designed to measure IgG antibodies directed to gliadin in serum or plasma to aid in the diagnosis of celiac disease. It is used with the Phadia 2500EE instrument. Phadia US Inc is recalling 568 units of this diagnostic test (Material Number 12410002) distributed in California, New Jersey, and Michigan.
The test well produces higher reported results when used on the Phadia 2500EE instrument compared to the same test well on the Phadia 250 instrument. This inconsistency could result in inaccurate test results and potential misdiagnosis of celiac disease.
Healthcare providers and laboratories using this test well with the Phadia 2500EE instrument may be affected by this recall.
Affected healthcare facilities should discontinue use of the recalled test wells and contact Phadia US Inc for instructions regarding proper handling, remediation steps, and testing procedures to ensure accurate results.
The recalled product
- 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 di
- Manufacturer
- Phadia US Inc
- Affected units
- 568
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 07333066010847 All lots
Distribution
Part of a larger recall action
This product is one of 2 recalled by Phadia US Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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