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
Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK 2.4 wireless blood glucose monitoring system (glucometer, test strips and control solution) is designed for self-testing by persons with diabetes and the monitoring of glucose concentrations for quantitative glucose measurement in fresh capillary full blood removed from the user's fingertips or palms. It is only for in vitro diagnostic use.
CONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and distributed. This meter contains the incorrect unit of measure mg/dL instead of mmol/L.
These labels are deterministic app interpretations, not FDA categories.
CONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and distributed. This meter contains the incorrect unit of measure mg/dL instead of mmol/L.
Code information
Lot# MD04M051P S/N# BG1245623B and S/N# BG1245624B
