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2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §866.3172 (Microbiology panel).

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FDA MAUDE casebook

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

#402 of 1000 · 3,089 reports · 1997–2026

  • BOOK 3,089 reports
  • RANK #402 of 1000
  • DEATH 2 death-typed
  • INJ 21 injury-typed
  • MALF 2,911 malfunction
  • SPAN 1997–2026
  • PEAK 2025: 383
  • PHOTO Prosthesis, Esophageal

Nearest event-volume peer: Prosthesis, Esophageal (5 report gap)

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) sits #402 of 1000 among tracked device types with 3,089 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 →

Injury-coded reports sit below the device-type norm

Test, Hepatitis B carries 0.7% INJURY-coded reports, 29.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 0.7% corpus 30.3% · below corpus mean (-29.6 pp)
  • MALF 94.2% corpus 64.8% · above corpus mean (+29.4 pp)

Lead product-problem code False Positive Result is 33% of coded problems · Lead manufacturer SIEMENS HEALTHCARE DIAGNOSTICS, INC. accounts for 29% of manufacturer-tagged reports · Top event location is 72% 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 3,089 MAUDE reports, ranked #402 of 1000.

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

Event Types

Malfunction 2,911 (94.2%)
Other 132 (4.3%)
23 (0.7%)
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.

3,019 (98.1%)
Other 37 (1.2%)
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 1,076
False Negative Result 814
High Test Results 371
Incorrect Or Inadequate Test Results 267
Low Test Results 172
Incorrect, Inadequate or Imprecise Result or Readings 129
Adverse Event Without Identified Device or Use Problem 120
Non Reproducible Results 113
No Apparent Adverse Event 112
Incorrect Measurement 19
Defective Device 16
Improper or Incorrect Procedure or Method 15
Nonstandard Device 12
Replace 8
Detachment Of Device Component 7
Other (for use when an appropriate device code cannot be identified) 7
Output Problem 7
Use of Incorrect Control/Treatment Settings 7
False Reading From Device Non-Compliance 6
Insufficient Device Problem Information 6

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: 383
26
2026: 215

Reports rose to 383 in 2025, up from an average of 180 in the two years before - a recent-year increase, not a lifetime pattern.

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

Top Manufacturers

SIEMENS HEALTHCARE DIAGNOSTICS, INC. 545
ROCHE DIAGNOSTICS 472
ORTHO-CLINICAL DIAGNOSTICS 437
SIEMENS HEALTHCARE DIAGNOSTICS INC. 201
ABBOTT GMBH 131
ABBOTT LABORATORIES 112

Event Locations

2,228 (72.1%)
I 819 (26.5%)
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 ROCHE DIAGNOSTICS →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Test, Hepatitis B: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (3,089 here).

Prosthesis, Esophageal 3,094 Joint, Temporomandibular, Implant 3,096 Ventilator, High Frequency 3,097 Accelerator, Linear, Medical 3,068

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 Bed, Pediatric Open Hospital 2 Blade 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.