Hepatitis A Test (Antibody And Igm Antibody)
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §866.3310 (Microbiology panel).
FDA MAUDE casebook
openFDA event book Hepatitis A Test LIGHT-BOOK · MAUDE
#669 of 1000 · 982 reports · 2002–2026
- BOOK 982 reports
- RANK #669 of 1000
- DEATH 0 death-typed
- INJ 2 injury-typed
- MALF 958 malfunction
- SPAN 2002–2026
- PEAK 2011: 353
- PHOTO Midline Catheter
Nearest event-volume peer: Midline Catheter (1 report gap)
Hepatitis A Test (Antibody And Igm Antibody) sits #669 of 1000 among tracked device types with 982 MAUDE reports spanning 2002–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Malfunction reports run above the device-type norm
Hepatitis A Test carries 97.6% MALFUNCTION-coded reports, 32.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 0.2% corpus 30.3% · below corpus mean (-30.1 pp)
- MALF 97.6% corpus 64.8% · above corpus mean (+32.7 pp)
Lead product-problem code False Positive Result is 22% of coded problems · Lead manufacturer ABBOTT accounts for 43% of manufacturer-tagged reports · Top event location is 69% of location-tagged rows .
Hepatitis A Test in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Pack
Pack, Hot Or Cold, Water Circulating
984 reports
- Midline Cathe…
Midline Catheter
983 reports
- Hepatitis A T… (this)
Hepatitis A Test (Antibody And Igm Antibody)
982 reports
- Single-Use Re…
Single-Use Reprocessed Ultrasonic Surgical Instruments
980 reports
- Container
Container, Sharps
979 reports
- Bronchoscope…
Bronchoscope Accessory
977 reports
What this shows Hepatitis A Test (Antibody And Igm Antibody) carries 982 MAUDE reports, ranked #669 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (20) held close to the prior two-year average of 29.
Related Entities for Hepatitis A Test (Antibody And Igm Antibody)
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
Hepatitis A Test carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (982 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Hepatitis A Test are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Hepatitis A Test; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.