openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 1
Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.
Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false positive samples.
These labels are deterministic app interpretations, not FDA categories.
Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false positive samples.
