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
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.
These labels are deterministic app interpretations, not FDA categories.
Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.
