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2020 data FDA MAUDE openFDA FDA Class III

System, Identification, Hepatitis B 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 System, Identification, Hepatitis B Antigen LIGHT-BOOK · MAUDE

#914 of 1000 · 472 reports · 1997–2020

  • BOOK 472 reports
  • RANK #914 of 1000
  • DEATH 0 death-typed
  • INJ 17 injury-typed
  • MALF 453 malfunction
  • SPAN 1997–2020
  • PEAK 2018: 79
  • PHOTO Implantable Transpros…

Nearest event-volume peer: Implantable Transprostatic Tissue Retractor System (1 report gap)

System, Identification, Hepatitis B Antigen sits #914 of 1000 among tracked device types with 472 MAUDE reports spanning 1997–2020. 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

System, Identification, Hepatitis B Antigen carries 96.0% MALFUNCTION-coded reports, 31.1pp 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 3.6% corpus 30.3% · below corpus mean (-26.7 pp)
  • MALF 96.0% corpus 64.8% · above corpus mean (+31.1 pp)

Lead product-problem code False Negative Result is 38% of coded problems · Lead manufacturer ABBOTT LABORATORIES accounts for 97% of manufacturer-tagged reports · Top event location I is 55% of location-tagged rows .

System, Identification, Hepatitis B Antigen in the event-volume neighbourhood

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

reports

What this shows System, Identification, Hepatitis B Antigen carries 472 MAUDE reports, ranked #914 of 1000.

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

Event Types

Malfunction 453 (96.0%)
Injury 17 (3.6%)
Other 2 (0.4%)

Patient Outcomes

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

448 (94.9%)
Other 21 (4.4%)
Required Intervention 2 (0.4%)
Disability 1 (0.2%)

Top Product Problems

False Negative Result 185
False Positive Result 146
High Test Results 57
Incorrect Or Inadequate Test Results 54
Low Test Results 29
Incorrect, Inadequate or Imprecise Result or Readings 4
Device Operates Differently Than Expected 2
Adverse Event Without Identified Device or Use Problem 1
False Reading From Device Non-Compliance 1
High Readings 1
Imprecision 1
Improper or Incorrect Procedure or Method 1
Low Readings 1
Performance 1

Yearly Trend

97
1997: 2
04
2004: 1
05
2005: 2
07
2007: 23
08
2008: 4
09
2009: 40
10
2010: 22
11
2011: 23
12
2012: 37
13
2013: 22
14
2014: 32
15
2015: 12
16
2016: 30
17
2017: 71
18
2018: 79
19
2019: 65
20
2020: 7

Reports in 2019 (65) held close to the prior two-year average of 75.

Related Entities for System, Identification, Hepatitis B Antigen

Top Manufacturers

ABBOTT LABORATORIES 114
ORTHO-CLINICAL DIAGNOSTICS 3
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1

Event Locations

I 260 (55.1%)
210 (44.5%)
INVALID DATA 2 (0.4%)

Compare ABBOTT LABORATORIES vs ORTHO-CLINICAL DIAGNOSTICS →

Nationwide devices with a comparable report-volume footprint

System, Identification, Hepatitis B Antigen 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 (472 here).

Implantable Transprostatic Tissue Retractor… 471 Microscope, Surgical 473 Heart-Valve, Allograft 474 Mask, Oxygen 470

Similar death-typed counts

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

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for System, Identification, Hepatitis B Antigen 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 System, Identification, Hepatitis B Antigen; 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.