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2026 data FDA MAUDE openFDA FDA Class II

Test, Hiv Detection

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 §866.3956 (Microbiology panel).

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FDA MAUDE casebook

openFDA event book Test, Hiv Detection LIGHT-BOOK · MAUDE

#390 of 1000 · 3,187 reports · 2002–2026

  • BOOK 3,187 reports
  • RANK #390 of 1000
  • DEATH 4 death-typed
  • INJ 123 injury-typed
  • MALF 2,972 malfunction
  • SPAN 2002–2026
  • PEAK 2025: 1,090
  • PHOTO System

Nearest event-volume peer: System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer (3 report gap)

Test, Hiv Detection sits #390 of 1000 among tracked device types with 3,187 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 →

Malfunction reports run above the device-type norm

Test, Hiv Detection carries 93.3% MALFUNCTION-coded reports, 28.4pp above 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 3.9% corpus 30.3% · below corpus mean (-26.4 pp)
  • MALF 93.3% corpus 64.8% · above corpus mean (+28.4 pp)

Lead product-problem code False Positive Result is 64% of coded problems · Lead manufacturer ABBOTT DIAGNOSTICS SCARBOROUGH, INC. accounts for 49% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .

Test, Hiv Detection in the event-volume neighbourhood

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

reports

What this shows Test, Hiv Detection carries 3,187 MAUDE reports, ranked #390 of 1000.

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

Event Types

Malfunction 2,972 (93.3%)
Injury 123 (3.9%)
61 (1.9%)
Other 27 (0.8%)
Death 4 (0.1%)

Patient Outcomes

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

3,012 (94.5%)
Other 99 (3.1%)
Disability 21 (0.7%)
Required Intervention 21 (0.7%)
Hospitalization 18 (0.6%)
O 5 (0.2%)
Life Threatening 4 (0.1%)
L 2 (0.1%)
S 2 (0.1%)
D 1 (0.0%)
R 1 (0.0%)
Congenital Anomaly 1 (0.0%)
Death 1 (0.0%)

Top Product Problems

False Positive Result 2,143
False Negative Result 489
Incorrect, Inadequate or Imprecise Result or Readings 186
Non Reproducible Results 136
Incorrect Or Inadequate Test Results 80
Low Test Results 75
High Test Results 55
Adverse Event Without Identified Device or Use Problem 48
Output Problem 26
Improper or Incorrect Procedure or Method 17
Leak/Splash 16
Calibration Error 14
No Apparent Adverse Event 14
Imprecise or Erratic Results 9
Device Operates Differently Than Expected 7
Use of Device Problem 7
Insufficient Device Problem Information 6
Appropriate Device Problem Term/Code Not Available 5
Incorrect Measurement 5
Nonstandard Device 5

Yearly Trend

02
2002: 1
03
2003: 1
05
2005: 5
06
2006: 3
07
2007: 4
08
2008: 8
09
2009: 18
10
2010: 44
11
2011: 92
12
2012: 69
13
2013: 47
14
2014: 49
15
2015: 74
16
2016: 79
17
2017: 135
18
2018: 580
19
2019: 154
20
2020: 66
21
2021: 65
22
2022: 114
23
2023: 88
24
2024: 114
25
2025: 1,090
26
2026: 287

Reports rose to 1,090 in 2025, up from an average of 101 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Test, Hiv Detection

Top Manufacturers

ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 983
ROCHE DIAGNOSTICS 532
ABBOTT GMBH 177
ABBOTT LABORATORIES 172
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 85
ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG 65

Event Locations

2,068 (64.9%)
I 1,106 (34.7%)
NO INFORMATION 6 (0.2%)
UNKNOWN 3 (0.1%)
HOSPITAL 2 (0.1%)
HOME 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare ABBOTT DIAGNOSTICS SCARBOROUGH, INC. vs ROCHE DIAGNOSTICS →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Test, Hiv Detection: 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 (3,187 here).

System 3,190 Catheter, Hemodialysis, Non-Implanted 3,199 System 3,169 Apparatus, Autotransfusion 3,163

Similar death-typed counts

Nearest other device types by death-typed report count (4 here), distinct from the volume row.

Catheter, Urethral 4 Disinfectant, Medical Devices 4 Drill, Surgical, Ent Including Handpiece 4 Electrode 4

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

Disclaimer: MAUDE figures for Test, Hiv Detection 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, Hiv Detection; 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.