Home › DIAMEDIX CORPORATION › Diamedix
Diamedix
DIAMEDIX CORPORATION · Model 720-440 · UDI-DI 00817273020259
1
510(k) clearances
3
Adverse events (1 deaths)
1
Recalls
25
Facilities
Description
"720-440 anti-PR-3 (C-ANCA) IgG Test Kit"
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.