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 2
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
Due to products distributed without premarket clearance or approvals.
Code information
Lot Code: Model No: eB-U01 UDI-DI: (01)04712558761116 eBuricacid Meter Kit, (01)04712558761123 eBuricacid Test Strips 25pcs, (01)04712558761208 eBuricacid Test Strips 10pcs*4 Lot Numbers: All lots manufactured up to Oct. 13, 2023 Serial Numbers: All lots manufactured up to Oct. 13, 2023 Software Revisions: Firmware v1.0 Expiration Dates: Test strips: up to 2025-04-14
Distribution pattern
Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.
device · product 2 of 2
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
Due to products distributed without premarket clearance or approvals.
Code information
Lot Code: Model No: eB-U01 UDI-DI: None. Lot Numbers: All lots manufactured up to Jun. 20, 2022 Serial Numbers: All lots manufactured up to Jun. 20, 2022 Software Revisions: Firmware v1.0 Expiration Dates: Test strips: up to 2023-12-19
Distribution pattern
Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.
