2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Hepatitis A Test LIGHT-BOOK · MAUDE

#665 of 1000 · 977 reports · 2002–2026

  • BOOK 977 reports
  • RANK #665 of 1000
  • DEATH 0 death-typed
  • INJ 2 injury-typed
  • MALF 953 malfunction
  • SPAN 2002–2026
  • PEAK 2011: 353
  • PHOTO Container, Sharps

Nearest event-volume peer: Container, Sharps (0 report gap)

Hepatitis A Test (Antibody And Igm Antibody) sits #665 of 1000 among tracked device types with 977 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 0.2% corpus 30.4% · below corpus mean (-30.2 pp)
  • MALF 97.5% corpus 64.5% · above corpus mean (+33.0 pp)

Lead product-problem code False Positive Result is 43% 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

reports

What this shows Hepatitis A Test (Antibody And Igm Antibody) carries 977 MAUDE reports, ranked #665 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 953 (97.5%)
Other 17 (1.7%)
5 (0.5%)
Injury 2 (0.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

967 (99.1%)
Other 6 (0.6%)
Required Intervention 2 (0.2%)
Hospitalization 1 (0.1%)

Top Product Problems

False Positive Result 174
High Test Results 145
False Negative Result 25
Incorrect Or Inadequate Test Results 17
Adverse Event Without Identified Device or Use Problem 11
Incorrect, Inadequate or Imprecise Result or Readings 9
Low Test Results 6
Non Reproducible Results 6
Output Problem 5
Incorrect Measurement 2
Computer Software Problem 1
False Reading From Device Non-Compliance 1
High Readings 1
Insufficient Information 1
Optical Problem 1
Patient Data Problem 1

Yearly Trend

02
2002: 1
04
2004: 2
05
2005: 1
07
2007: 2
08
2008: 13
09
2009: 24
10
2010: 53
11
2011: 353
12
2012: 42
13
2013: 49
14
2014: 19
15
2015: 29
16
2016: 36
17
2017: 26
18
2018: 61
19
2019: 51
20
2020: 104
21
2021: 12
22
2022: 17
23
2023: 36
24
2024: 21
25
2025: 20
26
2026: 5

Related Entities for Hepatitis A Test (Antibody And Igm Antibody)

Event Locations

672 (68.8%)
I 295 (30.2%)
NO INFORMATION 3 (0.3%)
CLINIC - WALK IN, OTHER 2 (0.2%)
LABORATORY 2 (0.2%)
NOT APPLICABLE 2 (0.2%)
OTHER 1 (0.1%)

Compare ABBOTT vs ABBOTT GMBH →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Hepatitis A Test, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (977 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

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.