PlainHospital

ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

Manufacturer adverse-event records for ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 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 · 2019–2026 · mid-book · quiet Death-code · injury-light

Injury-mix signature

ABBOTT DIAGNOSTICS SCARBOROUGH, INC. is lighter on Injury codes

Injury-coded event_type share is 3.3% (injury-light tercile) beside 0.06% Death-coded (quiet). Volume band: mid.

What the Injury-mix reading shows for ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

The standout signal for ABBOTT DIAGNOSTICS SCARBOROUGH, INC. is Injury-mix: 3.3% Injury-coded (injury-light) beside 0.06% Death-coded, on a mid-book footprint.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for ABBOTT DIAGNOSTICS SCARBOROUGH, INC.. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 15 device types, led in this extract by Malfunction at 11,187 (96.6% of event_type total). Peak single-year volume reaches 4,912 reports across 8 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

11,576
Total Reports
7
Event-type Death
380
Injury Reports
15
Device Types

Event Types

Malfunction 11,187 (96.6%)
Injury 380 (3.3%)
Death 7 (0.1%)
2 (0.0%)

Patient Outcomes

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

10,902 (94.1%)
Other 508 (4.4%)
Hospitalization 95 (0.8%)
Disability 16 (0.1%)
Death 13 (0.1%)
O 11 (0.1%)
H 8 (0.1%)
Required Intervention 7 (0.1%)
R 5 (0.0%)
Congenital Anomaly 5 (0.0%)
Life Threatening 5 (0.0%)
D 3 (0.0%)
L 2 (0.0%)

Devices (15)

Device Reports
Reagents, 2019-Novel Coronavirus Nucleic Acid 5,410
Coronavirus Antigen Detection Test System. 5,020
Test, Hiv Detection 861
Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings 131
Over-The-Counter Covid-19 Antigen Test 83
Real Time Nucleic Acid Amplification System 35
Antisera, All Groups, Streptococcus Spp. 15
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening 7
Influenza A And Influenza B Multiplex Nucleic Acid Assay 3
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus 2
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System 2
Legionella, Spp., Elisa 2
Plasmodium Spp. Detection Reagents 2
System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies 2
Devices Detecting Influenza A, B, And C Virus Antigens 1

Yearly Trend

19
2019: 48
20
2020: 424
21
2021: 2,726
22
2022: 4,912
23
2023: 1,846
24
2024: 736
25
2025: 855
26
2026: 29

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