Device 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
Z-2041-2023
Product summary
- Firm
- Phadia US Inc
- Event
- Event 92365
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9 units
- Official record key
device-enforcement:Z-2041-2023
Official wording
Reason: 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
Code information: UDI: 07333066020938 All Serial Numbers
Distribution pattern: US: CA, NJ, MI
Derived failure modes
-
Unknown
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