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AccuDiag ™
Diagnostic Automation, Inc. · Model DACD-2553-1 · UDI-DI 00894175000237
8
510(k) clearances
5
Adverse events
1
Recalls
8
Facilities
Description
AccuDiag ™ dsDNA Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-12-14 | Phadia US Inc | Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results). |
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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.