ABBOTT DIAGNOSTICS DIVISION
Manufacturer adverse-event records for ABBOTT DIAGNOSTICS DIVISION come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.
FDA MAUDE device safety record · 2000–2020 · thin-book · typical Death-code · injury-light
Volume signature
ABBOTT DIAGNOSTICS DIVISION is a thinner MAUDE footprint
ABBOTT DIAGNOSTICS DIVISION accounts for 4,192 FDA MAUDE reports (#409 of 434, thin-book tercile). Death-coded event_type share is 0.10% (typical); Injury share 1.0% (injury-light).
What the volume reading shows for ABBOTT DIAGNOSTICS DIVISION
The standout signal for ABBOTT DIAGNOSTICS DIVISION is filing volume: 4,192 adverse-event reports in FDA MAUDE (#409 of 434, thin-book). Death-coded event_type share sits at 0.10% (typical).
As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.
Reports span 5 device types, led in this extract by Malfunction at 4,146 (98.9% of event_type total). Peak single-year volume reaches 2,291 reports across 16 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Yearly Trend
Read our methodology - how this data is sourced, computed, and verified.