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2020 data FDA MAUDE openFDA

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

#893 of 1000 · 472 reports · 1997–2020

  • BOOK 472 reports
  • RANK #893 of 1000
  • DEATH 0 death-typed
  • INJ 17 injury-typed
  • MALF 453 malfunction
  • SPAN 1997–2020
  • PEAK 2018: 79
  • PHOTO Agents

Nearest event-volume peer: Agents, Embolic, For Treatment Of Uterine Fibroids (1 report gap)

System, Identification, Hepatitis B Antigen sits #893 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 →

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 3.6% corpus 30.4% · below corpus mean (-26.8 pp)
  • MALF 96.0% corpus 64.5% · above corpus mean (+31.5 pp)

Lead product-problem code False Positive Result is 50% 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 #893 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 Positive Result 129
False Negative Result 57
High Test Results 30
Incorrect Or Inadequate Test Results 23
Low Test Results 14
Adverse Event Without Identified Device or Use Problem 1
High Readings 1
Improper or Incorrect Procedure or Method 1
Incorrect, Inadequate or Imprecise Result or Readings 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

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 similar MAUDE profiles

Two openFDA-derived peer sets for System, Identification, Hepatitis B Antigen, 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 (472 here).

Agents 471 Heart-Valve, Allograft 474 Clip, Hemostatic 468 Container, Specimen, Sterile 476

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.