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2026 data FDA MAUDE openFDA

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

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 Assay LIGHT-BOOK · MAUDE

#537 of 1000 · 1,611 reports · 1999–2026

  • BOOK 1,611 reports
  • RANK #537 of 1000
  • DEATH 1 death-typed
  • INJ 106 injury-typed
  • MALF 1,464 malfunction
  • SPAN 1999–2026
  • PEAK 2025: 210
  • PHOTO Microfilter

Nearest event-volume peer: Microfilter, Blood Transfusion (4 report gap)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus sits #537 of 1000 among tracked device types with 1,611 MAUDE reports spanning 1999–2026. 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 6.6% corpus 30.4% · below corpus mean (-23.9 pp)
  • MALF 90.9% corpus 64.5% · above corpus mean (+26.4 pp)

Lead product-problem code False Negative Result is 52% of coded problems · Lead manufacturer ABBOTT LABORATORIES accounts for 30% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .

Assay in the event-volume neighbourhood

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

reports

What this shows Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus carries 1,611 MAUDE reports, ranked #537 of 1000.

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

Event Types

Malfunction 1,464 (90.9%)
Injury 106 (6.6%)
Other 33 (2.0%)
7 (0.4%)
Death 1 (0.1%)

Patient Outcomes

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

1,475 (91.7%)
Disability 116 (7.2%)
Other 14 (0.9%)
Required Intervention 3 (0.2%)
Death 1 (0.1%)

Top Product Problems

False Negative Result 543
False Positive Result 164
Adverse Event Without Identified Device or Use Problem 102
Low Test Results 87
No Apparent Adverse Event 35
Incorrect, Inadequate or Imprecise Result or Readings 32
High Test Results 26
Incorrect Or Inadequate Test Results 20
Non Reproducible Results 16
Incorrect Measurement 4
Appropriate Term/Code Not Available 3
Leak/Splash 3
Improper or Incorrect Procedure or Method 2
Chemical Problem 1
Device Difficult to Maintain 1
False Reading From Device Non-Compliance 1
Insufficient Information 1
Low Readings 1
Material Integrity Problem 1
Output Problem 1

Yearly Trend

99
1999: 1
01
2001: 2
02
2002: 1
03
2003: 3
05
2005: 4
06
2006: 6
07
2007: 20
08
2008: 21
09
2009: 86
10
2010: 51
11
2011: 76
12
2012: 136
13
2013: 119
14
2014: 57
15
2015: 41
16
2016: 115
17
2017: 116
18
2018: 153
19
2019: 138
20
2020: 47
21
2021: 26
22
2022: 56
23
2023: 55
24
2024: 56
25
2025: 210
26
2026: 15

Related Entities for Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

Top Manufacturers

ABBOTT LABORATORIES 354
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 258
ROCHE DIAGNOSTICS 251
ABBOTT GMBH 197
ORTHO-CLINICAL DIAGNOSTICS 77
SIEMENS HEALTHCARE DIAGNOSTICS INC. 27

Event Locations

992 (61.6%)
I 603 (37.4%)
LABORATORY 9 (0.6%)
NO INFORMATION 2 (0.1%)
HOSPITAL 1 (0.1%)
INVALID DATA 1 (0.1%)
OTHER 1 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare ABBOTT LABORATORIES vs SIEMENS HEALTHCARE DIAGNOSTICS, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Assay, 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 (1,611 here).

Microfilter, Blood Transfusion 1,615 Retractor 1,615 Laryngoscope, Endoscope 1,616 Tricuspid Valve Repair Device 1,605

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Assay 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 Assay; 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.