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.
NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
These labels are deterministic app interpretations, not FDA categories.
NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
Code information
All lots
Distribution pattern
Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada.
device · product 2 of 2
Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.
NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
These labels are deterministic app interpretations, not FDA categories.
NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
Code information
All lots
Distribution pattern
Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada.
