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Autostat II Anti-PR 3
HYCOR BIOMEDICAL LLC · Model FGA11 · UDI-DI 00816879020113
10
510(k) clearances
3
Adverse events (1 deaths)
1
Recalls
25
Facilities
Description
96 well ELISA for the detection of anti-PR 3 antibodies in human serum
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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