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.
1 linked reportMalfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-06 | 0 | 1 |
| 2020-04 | 0 | 1 |
| 2021-01 | 0 | 2 |
| 2021-02 | 0 | 1 |
| 2021-03 | 0 | 1 |
| 2021-04 | 0 | 2 |
| 2021-06 | 0 | 3 |
| 2021-07 | 0 | 3 |
| 2021-08 | 0 | 2 |
| 2021-09 | 0 | 1 |
| 2021-11 | 0 | 5 |
| 2021-12 | 0 | 1 |
| 2022-01 | 0 | 11 |
| 2022-03 | 0 | 8 |
| 2022-06 | 0 | 3 |
| 2022-08 | 0 | 1 |
| 2022-10 | 0 | 1 |
| 2022-12 | 0 | 5 |
| 2023-02 | 0 | 13 |
| 2023-03 | 0 | 2 |
| 2023-04 | 0 | 4 |
| 2023-05 | 0 | 2.5 |
| 2023-06 | 0 | 7 |
| 2023-08 | 0 | 2 |
| 2023-09 | 0 | 1 |
| 2023-10 | 0 | 1 |
| 2023-11 | 0 | 2 |
| 2023-12 | 0 | 4 |
| 2024-01 | 0 | 1 |
| 2024-02 | 0 | 9 |
| 2024-03 | 0 | 4 |
| 2024-04 | 0 | 3 |
| 2024-05 | 0 | 3 |
| 2024-06 | 0 | 4 |
| 2024-07 | 0 | 1 |
| 2024-10 | 0 | 3 |
| 2024-11 | 0 | 6 |
| 2025-03 | 0 | 5 |
| 2025-05 | 0 | 6 |
| 2025-06 | 0 | 1 |
| 2025-07 | 1 | 4 |
| 2025-08 | 0 | 3 |
| 2025-09 | 0 | 28 |
| 2025-10 | 0 | 2.5 |
| 2025-11 | 0 | 10 |
| 2025-12 | 0 | 4 |
| 2026-01 | 0 | 7 |
| 2026-02 | 0 | 56 |
| 2026-03 | 0 | 1 |
| 2026-05 | 0 | 5 |
| 2026-06 | 0 | 4 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-07-01 | 3007606081-2025-00001 | Malfunction | Available | exact di |
Regulatory clearances
- 510(k)K133343Substantially equivalent (SESE) · 2014-01-31clearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2018-05-11 | VAI | Voluntary action indicated | Wondfo USA Co Ltd | 4 |
| 2018-05-11 | VAI | Voluntary action indicated | Wondfo USA Co Ltd | 4 |
Similar devices
- Acceava® Alere San Diego, Inc.
- Accutest Value+ Strep A Rapid Test Strip JANT PHARMACAL CORPORATION
- Areta Strep A Swab Test Strip (25 tests kit) EASY HEALTHCARE CORPORATION
- Areta Strep A Swab Test Strip (25 tests kit) EASY HEALTHCARE CORPORATION
- BD Veritor™ Plus CLIA-Waived Combo Pack BECTON, DICKINSON AND COMPANY
- BD Veritor™ Plus Laboratory Combo Pack BECTON, DICKINSON AND COMPANY
- BD Veritor™ System Laboratory Combo Pack BECTON, DICKINSON AND COMPANY
- BD Veritor™ System for Rapid Detection of Group A Strep CLIA-Waived Kit BECTON, DICKINSON AND COMPANY
- BioSign® Strep A Flip PRINCETON BIOMEDITECH CORPORATION
- BioSign® Strep A card PRINCETON BIOMEDITECH CORPORATION
- BioSign® Strep A card PRINCETON BIOMEDITECH CORPORATION
- BioStrep® A PRINCETON BIOMEDITECH CORPORATION
Select up to two to place side-by-side with this device.