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2026 data FDA MAUDE openFDA FDA Class II

Respiratory Virus Panel Nucleic Acid Assay System

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 §866.3980 (Microbiology panel).

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FDA MAUDE casebook

openFDA event book Respiratory Virus Panel Nucleic Acid Assay… LIGHT-BOOK · MAUDE

#726 of 1000 · 808 reports · 2011–2026

  • BOOK 808 reports
  • RANK #726 of 1000
  • DEATH 9 death-typed
  • INJ 4 injury-typed
  • MALF 795 malfunction
  • SPAN 2011–2026
  • PEAK 2021: 686
  • PHOTO Unit

Nearest event-volume peer: Unit, Neonatal Phototherapy (0 report gap)

Respiratory Virus Panel Nucleic Acid Assay System sits #726 of 1000 among tracked device types with 808 MAUDE reports spanning 2011–2026. 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

Respiratory Virus Panel Nucleic Acid Assay… carries 98.4% MALFUNCTION-coded reports, 33.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
  • INJ 0.5% corpus 30.3% · below corpus mean (-29.8 pp)
  • MALF 98.4% corpus 64.8% · above corpus mean (+33.6 pp)

Lead product-problem code False Positive Result is 55% of coded problems · Lead manufacturer ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG accounts for 100% of manufacturer-tagged reports · Top event location I is 92% of location-tagged rows .

Respiratory Virus Panel Nucleic Acid Assay… in the event-volume neighbourhood

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

reports

What this shows Respiratory Virus Panel Nucleic Acid Assay System carries 808 MAUDE reports, ranked #726 of 1000.

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

Event Types

Malfunction 795 (98.4%)
Death 9 (1.1%)
Injury 4 (0.5%)

Patient Outcomes

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

793 (98.1%)
Death 9 (1.1%)
Other 4 (0.5%)
H 1 (0.1%)
Hospitalization 1 (0.1%)

Top Product Problems

False Positive Result 755
Incorrect, Inadequate or Imprecise Result or Readings 297
Output Problem 269
Incorrect Or Inadequate Test Results 25
Unable to Obtain Readings 11
False Negative Result 8
Non Reproducible Results 7
Adverse Event Without Identified Device or Use Problem 1
Device Difficult to Setup or Prepare 1
Improper or Incorrect Procedure or Method 1
Labelling, Instructions for Use or Training Problem 1
No Apparent Adverse Event 1
Nonstandard Device 1
Optical Obstruction 1
Output below Specifications 1
Under-Sensing 1

Yearly Trend

11
2011: 2
12
2012: 1
14
2014: 52
15
2015: 1
16
2016: 36
17
2017: 1
18
2018: 1
19
2019: 2
20
2020: 17
21
2021: 686
22
2022: 2
23
2023: 1
24
2024: 3
25
2025: 2
26
2026: 1

Reports in 2025 (2) held close to the prior two-year average of 2.

Related Entities for Respiratory Virus Panel Nucleic Acid Assay System

Top Manufacturers

ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG 672
ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1

Event Locations

I 740 (91.6%)
59 (7.3%)
OUTPATIENT TREATMENT FACILITY 4 (0.5%)
HOSPITAL 2 (0.2%)
NO INFORMATION 2 (0.2%)
OTHER 1 (0.1%)

Compare ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG vs ABBOTT DIAGNOSTICS SCARBOROUGH, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Respiratory Virus Panel Nucleic Acid 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 (808 here).

Unit, Neonatal Phototherapy 808 Cannula, Ophthalmic 807 Intracranial Coil-Assist Stent 806 Lithotriptor 811

Similar death-typed counts

Nearest other device types by death-typed report count (9 here), distinct from the volume row.

Blood Establishment Computer Software And A… 9 Catheter, Conduction, Anesthetic 9 Choledochoscope And Accessories 9 Connector, Airway 9

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

Disclaimer: MAUDE figures for Respiratory Virus Panel Nucleic Acid 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 Respiratory Virus Panel Nucleic Acid 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.