Home › HYCOR BIOMEDICAL LLC › Autostat II Anti-Gliadin IgA
Autostat II Anti-Gliadin IgA
HYCOR BIOMEDICAL LLC · Model FGA20 · UDI-DI 00816879020205
10
510(k) clearances
0
Adverse events
3
Recalls
20
Facilities
Description
96 well ELISA for the detection of IgA Gliadin antibodies in human serum
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-01 | Phadia US Inc | 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 |
| 2023-05-01 | Phadia US Inc | 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 |
| 2008-03-21 | Diamedix Corporation | Standards and controls in the Is-anti-Gliadin IgG Test Kits are exhibiting low activity. A drop in the O.D.s the Positive Control could potentially recover low out of range (which |
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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.