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
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above
Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Release of Material/Component prior to receiving test results
Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.
