Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
16 linked reportsMalfunction 14Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2021-05 | 0 | 3 |
| 2021-06 | 0 | 4 |
| 2021-07 | 0 | 29 |
| 2021-08 | 0 | 48 |
| 2021-09 | 0 | 65 |
| 2021-10 | 0 | 19 |
| 2021-11 | 0 | 24 |
| 2021-12 | 0 | 44 |
| 2022-01 | 0 | 30 |
| 2022-02 | 0 | 15.33 |
| 2022-03 | 0 | 11.5 |
| 2022-04 | 0 | 19 |
| 2022-05 | 0 | 20.5 |
| 2022-06 | 0 | 15.25 |
| 2022-07 | 0 | 14 |
| 2022-08 | 0 | 13 |
| 2022-09 | 0 | 22 |
| 2022-10 | 0 | 44 |
| 2022-11 | 0 | 39.33 |
| 2022-12 | 0 | 30 |
| 2023-01 | 0 | 54.5 |
| 2023-02 | 0 | 26 |
| 2023-03 | 0 | 34.5 |
| 2023-04 | 0 | 45 |
| 2023-05 | 0 | 35 |
| 2023-06 | 0 | 18 |
| 2023-07 | 0 | 17 |
| 2023-08 | 0 | 20 |
| 2023-09 | 0 | 14.67 |
| 2023-10 | 0 | 75 |
| 2023-11 | 0 | 58 |
| 2023-12 | 0 | 17.67 |
| 2024-01 | 0 | 32 |
| 2024-02 | 0 | 31.5 |
| 2024-03 | 0 | 14 |
| 2024-04 | 0 | 6 |
| 2024-05 | 0 | 4 |
| 2024-06 | 0 | 1.5 |
| 2024-07 | 0 | 6 |
| 2024-08 | 0 | 7.75 |
| 2024-09 | 0 | 4 |
| 2024-10 | 0 | 5 |
| 2024-11 | 3 | 2.75 |
| 2024-12 | 2 | 5.5 |
| 2025-01 | 9 | 6.75 |
| 2025-02 | 0 | 1.5 |
| 2025-03 | 0 | 4.5 |
| 2025-04 | 0 | 3 |
| 2025-05 | 0 | 1 |
| 2025-06 | 2 | 3 |
| 2025-07 | 0 | 1 |
| 2025-08 | 0 | 2 |
| 2025-09 | 0 | 1.5 |
| 2025-10 | 0 | 5 |
| 2025-11 | 0 | 5.5 |
| 2025-12 | 0 | 4 |
| 2026-01 | 0 | 2 |
| 2026-02 | 0 | 4 |
| 2026-03 | 0 | 3 |
| 2026-04 | 0 | 2 |
| 2026-05 | 0 | 2 |
Failure-mode summaryAI-generated
16 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-06-25 | 0002024674-2025-00437 | Malfunction | Available | exact di |
| 2025-06-25 | 0002024674-2025-00436 | Malfunction | Available | exact di |
| 2025-01-23 | 0002024674-2025-00120 | Malfunction | Available | exact di |
| 2025-01-23 | 0002024674-2025-00121 | Malfunction | Available | exact di |
| 2025-01-13 | 0002024674-2025-00045 | Malfunction | Available | exact di |
| 2025-01-13 | 0002024674-2025-00047 | Malfunction | Available | exact di |
| 2025-01-13 | 0002024674-2025-00049 | Malfunction | Available | exact di |
| 2025-01-13 | 0002024674-2025-00043 | Injury | Available | exact di |
| 2025-01-13 | 0002024674-2025-00048 | Malfunction | Available | exact di |
| 2025-01-13 | 0002024674-2025-00046 | Malfunction | Available | exact di |
| 2025-01-13 | 0002024674-2025-00050 | Malfunction | Available | exact di |
| 2024-12-10 | 0002024674-2024-00804 | Malfunction | Available | exact di |
| 2024-12-10 | 0002024674-2024-00892 | Malfunction | Available | exact di |
| 2024-11-15 | 0002024674-2024-00538 | Injury | Available | exact di |
| 2024-11-08 | 0002024674-2024-00687 | Malfunction | Available | exact di |
Showing 1–15 of 16
Regulatory clearances
- 510(k)K231795Substantially equivalent (SESE) · 2024-03-22clearance family
Manufacturer compliance record
None in the loaded window.
Similar devices
- BinaxNOW COVID-19 Antigen Self Test Alere Scarborough, Inc.
- BinaxNOW COVID-19 Antigen Self Test Alere Scarborough, Inc.
- BinaxNOW COVID-19 Antigen Self Test Alere Scarborough, Inc.
- BinaxNOW COVID-19 Antigen Self Test Alere Scarborough, Inc.
- CASE SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box WatMIND USA
- CASE SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 2 Tests/Box WatMIND USA
- CASE SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 25 Tests/Box WatMIND USA
- CASE SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 4 Tests/Box WatMIND USA
- CASE-RDB-SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box WatMIND USA
- CASE-RDB-SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 2 Tests/Box WatMIND USA
- COVID-19 Detect™ Rapid Self -Test INBIOS INTERNATIONAL, INC
- CareSuperb COVID-19 Antigen Home Test Access Bio Inc.
Select up to two to place side-by-side with this device.