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
Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.
These labels are deterministic app interpretations, not FDA categories.
Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.
