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ANTI-MPO (pANCA)
ORGENTEC Diagnostika GmbH · Model ORG519 · UDI-DI 04260157080188
MOB
Prescription
10
510(k) clearances
3
Adverse events (1 deaths)
1
Recalls
25
Facilities
Description
Anti-MPO is an ELISA test system for the quantitative measurement of IgG class autoantibodies against myeloperoxidase (MPO) in human serum or plasma. This product is intended for professional in vitro diagnostic use only.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-24 | Phadia Ab | Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA w |
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