Phadia 2500EE diagnostic instrument recalled for measurement inaccuracy
Phadia US Inc is recalling the Phadia 2500EE diagnostic instrument. The device produces higher reported results compared to the baseline Phadia 250 instrument.
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 an FDA Class II device recall with no reported illnesses, injuries, or adverse events. The hazard is a measurement accuracy variance without reported harm. With only 9 units affected, this precautionary recall warrants a Moderate severity score.
Plain-English summary
Phadia US Inc has issued a recall of the Phadia 2500EE diagnostic instrument. This device measures IgG antibodies to gliadin in human serum or plasma to provide diagnostic support for celiac disease. The device's material number is 12410002.
The recall was initiated because the Phadia 2500EE produces higher reported results compared to the baseline Phadia 250 instrument when running the EliA GliadinDP IgG Well assay. The measurement discrepancy between the two instruments was identified during testing.
The recall affects 9 units distributed to facilities in California, New Jersey, and Michigan. All serial numbers are included in this recall.
The recalled product
- 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
- Manufacturer
- Phadia US Inc
- Hazard
- Affected units
- 9
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: 07333066020938 All Serial Numbers
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.
See all 2 products in this recall →Related recalls
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