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2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §866.3169 (Microbiology panel).

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FDA MAUDE casebook

openFDA event book Assay LIGHT-BOOK · MAUDE

#540 of 1000 · 1,668 reports · 1999–2026

  • BOOK 1,668 reports
  • RANK #540 of 1000
  • DEATH 1 death-typed
  • INJ 106 injury-typed
  • MALF 1,521 malfunction
  • SPAN 1999–2026
  • PEAK 2025: 210
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Percutaneous, Neurovasculature (1 report gap)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus sits #540 of 1000 among tracked device types with 1,668 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 →

Malfunction reports run above the device-type norm

Assay carries 91.2% MALFUNCTION-coded reports, 26.4pp 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 6.4% corpus 30.3% · below corpus mean (-23.9 pp)
  • MALF 91.2% corpus 64.8% · above corpus mean (+26.4 pp)

Lead product-problem code False Negative Result is 48% of coded problems · Lead manufacturer ABBOTT LABORATORIES accounts for 29% of manufacturer-tagged reports · Top event location is 63% 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 1,668 MAUDE reports, ranked #540 of 1000.

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

Event Types

Malfunction 1,521 (91.2%)
Injury 106 (6.4%)
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.

1,529 (91.9%)
Disability 116 (7.0%)
Other 14 (0.8%)
Required Intervention 3 (0.2%)
Death 1 (0.1%)

Top Product Problems

False Negative Result 840
False Positive Result 350
Low Test Results 115
Incorrect Or Inadequate Test Results 110
Adverse Event Without Identified Device or Use Problem 106
High Test Results 65
Incorrect, Inadequate or Imprecise Result or Readings 58
No Apparent Adverse Event 35
Non Reproducible Results 25
Defective Device 15
Improper or Incorrect Procedure or Method 8
Nonstandard Device 8
Appropriate Device Problem Term/Code Not Available 4
Incorrect Measurement 4
Leak/Splash 3
Device Operates Differently Than Expected 2
Insufficient Device Problem Information 2
Bubble(s) 1
Calibration Error 1
Chemical 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: 72

Reports rose to 210 in 2025, up from an average of 56 in the two years before - a recent-year increase, not a lifetime pattern.

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

Top Manufacturers

ABBOTT LABORATORIES 354
ROCHE DIAGNOSTICS 288
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 258
ABBOTT GMBH 210
ORTHO-CLINICAL DIAGNOSTICS 77
SIEMENS HEALTHCARE DIAGNOSTICS INC. 27

Event Locations

1,049 (62.9%)
I 603 (36.2%)
LABORATORY 9 (0.5%)
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 ROCHE DIAGNOSTICS →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Assay: 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 (1,668 here).

Catheter, Percutaneous, Neurovasculature 1,669 Laryngoscope, Endoscope 1,664 Adhesive 1,663 Positioner, Tooth, Preformed 1,674

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.