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ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG

Manufacturer adverse-event records for ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2020–2026 · thin-book · quiet Death-code · injury-light

Injury-mix signature

ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG is lighter on Injury codes

Injury-coded event_type share is 0.2% (injury-light tercile) beside 0.02% Death-coded (quiet). Volume band: thin.

What the Injury-mix reading shows for ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG

The standout signal for ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG is Injury-mix: 0.2% Injury-coded (injury-light) beside 0.02% Death-coded, on a thin-book footprint.

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 20 device types, led in this extract by Malfunction at 6,354 (99.8% of event_type total). Peak single-year volume reaches 3,858 reports across 7 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

6,367
Total Reports
1
Event-type Death
12
Injury Reports
20
Device Types

Event Types

Malfunction 6,354 (99.8%)
Injury 12 (0.2%)
Death 1 (0.0%)

Patient Outcomes

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

6,340 (99.8%)
Required Intervention 6 (0.1%)
Other 5 (0.1%)
Death 2 (0.0%)
H 1 (0.0%)

Devices (20)

Device Reports
Reagents, 2019-Novel Coronavirus Nucleic Acid 3,431
Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices 1,652
Respiratory Virus Panel Nucleic Acid Assay System 672
Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations 363
Somatic Gene Mutation Detection System 120
Test, Hiv Detection 57
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus 18
Test, Equipment, Automated Bloodborne Pathogen 13
Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test 9
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents 6
Clinical Sample Concentrator 5
Hepatitis Viral B Dna Detection 5
Dna Probe, Nucleic Acid Amplification, Chlamydia 3
Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test 2
Station, Pipetting And Diluting, For Clinical Use 2
Analyzer, Chemistry, Micro, For Clinical Use 1
Kit, Dna Detection, Human Papillomavirus 1
Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna 1
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections 1
Respiratory Specimen Nucleic Acid Sars-Cov-2 Test 1

Yearly Trend

20
2020: 503
21
2021: 3,858
22
2022: 1,079
23
2023: 326
24
2024: 145
25
2025: 435
26
2026: 21

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