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2026 data FDA MAUDE openFDA

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

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.

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FDA MAUDE casebook

openFDA event book Test, Hepatitis B LIGHT-BOOK · MAUDE

#400 of 1000 · 2,938 reports · 1997–2026

  • BOOK 2,938 reports
  • RANK #400 of 1000
  • DEATH 2 death-typed
  • INJ 21 injury-typed
  • MALF 2,760 malfunction
  • SPAN 1997–2026
  • PEAK 2025: 384
  • PHOTO Dilator

Nearest event-volume peer: Dilator, Vessel, For Percutaneous Catheterization (9 report gap)

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) sits #400 of 1000 among tracked device types with 2,938 MAUDE reports spanning 1997–2026. 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 0.1% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 0.7% corpus 30.4% · below corpus mean (-29.7 pp)
  • MALF 93.9% corpus 64.5% · above corpus mean (+29.4 pp)

Lead product-problem code False Positive Result is 34% of coded problems · Lead manufacturer SIEMENS HEALTHCARE DIAGNOSTICS, INC. accounts for 30% of manufacturer-tagged reports · Top event location is 71% of location-tagged rows .

Test, Hepatitis B in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) carries 2,938 MAUDE reports, ranked #400 of 1000.

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

Event Types

Malfunction 2,760 (93.9%)
Other 132 (4.5%)
23 (0.8%)
Injury 21 (0.7%)
Death 2 (0.1%)

Patient Outcomes

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

2,863 (97.9%)
Other 37 (1.3%)
Required Intervention 7 (0.2%)
Disability 4 (0.1%)
Hospitalization 4 (0.1%)
D 1 (0.0%)
L 1 (0.0%)
O 1 (0.0%)
R 1 (0.0%)
S 1 (0.0%)
Congenital Anomaly 1 (0.0%)
Death 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

False Positive Result 646
False Negative Result 415
High Test Results 285
Low Test Results 130
No Apparent Adverse Event 112
Adverse Event Without Identified Device or Use Problem 97
Non Reproducible Results 78
Incorrect, Inadequate or Imprecise Result or Readings 68
Incorrect Or Inadequate Test Results 41
Incorrect Measurement 13
Improper or Incorrect Procedure or Method 7
Use of Incorrect Control/Treatment Settings 7
Output Problem 5
Insufficient Information 4
Leak/Splash 4
Appropriate Term/Code Not Available 3
Calibration Problem 1
Chemical Problem 1
Device Contamination with Body Fluid 1
Device Damaged Prior to Use 1

Yearly Trend

97
1997: 3
98
1998: 1
99
1999: 2
00
2000: 3
01
2001: 3
02
2002: 7
03
2003: 15
04
2004: 27
05
2005: 23
06
2006: 14
07
2007: 72
08
2008: 64
09
2009: 128
10
2010: 93
11
2011: 132
12
2012: 140
13
2013: 174
14
2014: 129
15
2015: 139
16
2016: 146
17
2017: 88
18
2018: 112
19
2019: 191
20
2020: 139
21
2021: 147
22
2022: 139
23
2023: 163
24
2024: 197
25
2025: 384
26
2026: 63

Related Entities for Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Top Manufacturers

SIEMENS HEALTHCARE DIAGNOSTICS, INC. 544
ORTHO-CLINICAL DIAGNOSTICS 437
ROCHE DIAGNOSTICS 395
SIEMENS HEALTHCARE DIAGNOSTICS INC. 200
ABBOTT GMBH 114
ABBOTT LABORATORIES 112

Event Locations

2,077 (70.7%)
I 819 (27.9%)
OTHER 16 (0.5%)
LABORATORY 13 (0.4%)
AMBULATORY SURGICAL FACILITY 4 (0.1%)
NO INFORMATION 3 (0.1%)
HOSPITAL 2 (0.1%)
INVALID DATA 2 (0.1%)
NURSING HOME 2 (0.1%)

Compare SIEMENS HEALTHCARE DIAGNOSTICS, INC. vs ORTHO-CLINICAL DIAGNOSTICS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Test, Hepatitis B, 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 (2,938 here).

Dilator 2,929 Test, Hiv Detection 2,947 Agent, Injectable, Embolic 2,957 Assay, Glycosylated Hemoglobin 2,919

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Analyzer, Chemistry Clinical Use 2 Bed, Pediatric Open Hospital 2

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Test, Hepatitis B 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 Test, Hepatitis B; 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.