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.
27 linked reportsMalfunction 27
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.67 |
| 2019-02 | 0 | 1.75 |
| 2019-03 | 0 | 1.5 |
| 2019-04 | 0 | 3.25 |
| 2019-05 | 0 | 2.67 |
| 2019-06 | 1 | 1.91 |
| 2019-07 | 0 | 1.57 |
| 2019-08 | 1 | 1.57 |
| 2019-09 | 0 | 6.24 |
| 2019-10 | 0 | 2.33 |
| 2019-11 | 0 | 1.86 |
| 2019-12 | 1 | 3.6 |
| 2020-01 | 0 | 1.33 |
| 2020-02 | 2 | 4 |
| 2020-03 | 0 | 1.5 |
| 2020-04 | 0 | 2.75 |
| 2020-06 | 0 | 1 |
| 2020-07 | 1 | 1.5 |
| 2020-08 | 0 | 2 |
| 2020-09 | 0 | 3.4 |
| 2020-10 | 0 | 2 |
| 2020-11 | 0 | 2.8 |
| 2020-12 | 0 | 1.73 |
| 2021-01 | 0 | 3 |
| 2021-02 | 1 | 2 |
| 2021-03 | 1 | 2 |
| 2021-04 | 1 | 2.13 |
| 2021-05 | 0 | 2.5 |
| 2021-06 | 0 | 2 |
| 2021-07 | 0 | 1.17 |
| 2021-08 | 0 | 1.5 |
| 2021-09 | 0 | 3.67 |
| 2021-10 | 0 | 2.25 |
| 2021-11 | 0 | 2 |
| 2021-12 | 1 | 3.25 |
| 2022-01 | 0 | 3 |
| 2022-02 | 1 | 2.4 |
| 2022-03 | 1 | 5 |
| 2022-04 | 1 | 2.33 |
| 2022-05 | 0 | 3.63 |
| 2022-06 | 0 | 2.67 |
| 2022-07 | 0 | 4.33 |
| 2022-08 | 0 | 2.14 |
| 2022-09 | 0 | 2.5 |
| 2022-10 | 1 | 2 |
| 2022-11 | 0 | 3 |
| 2022-12 | 0 | 3.67 |
| 2023-01 | 0 | 1 |
| 2023-02 | 0 | 4.33 |
| 2023-03 | 2 | 1.88 |
| 2023-04 | 0 | 2 |
| 2023-05 | 0 | 2.38 |
| 2023-06 | 0 | 1.5 |
| 2023-07 | 0 | 1.5 |
| 2023-08 | 0 | 2.75 |
| 2023-09 | 0 | 3.75 |
| 2023-10 | 0 | 1.36 |
| 2023-11 | 1 | 2.29 |
| 2023-12 | 0 | 4 |
| 2024-01 | 0 | 2.5 |
| 2024-02 | 0 | 2.2 |
| 2024-03 | 0 | 1.2 |
| 2024-04 | 0 | 1.63 |
| 2024-05 | 0 | 2.13 |
| 2024-06 | 0 | 3 |
| 2024-07 | 0 | 2.5 |
| 2024-08 | 0 | 5.33 |
| 2024-09 | 1 | 2.58 |
| 2024-10 | 1 | 2.1 |
| 2024-11 | 0 | 3 |
| 2024-12 | 1 | 3 |
| 2025-01 | 1 | 3.08 |
| 2025-02 | 0 | 3.14 |
| 2025-03 | 2 | 2.2 |
| 2025-04 | 0 | 3.67 |
| 2025-05 | 0 | 2.8 |
| 2025-06 | 1 | 4.14 |
| 2025-07 | 0 | 2 |
| 2025-08 | 0 | 2.67 |
| 2025-09 | 1 | 1.75 |
| 2025-10 | 0 | 3.33 |
| 2025-11 | 1 | 3.8 |
| 2025-12 | 1 | 1.71 |
| 2026-01 | 0 | 2.14 |
| 2026-02 | 0 | 2.57 |
| 2026-03 | 0 | 1.89 |
| 2026-04 | 0 | 2.5 |
| 2026-05 | 0 | 5.4 |
| 2026-06 | 0 | 2.82 |
Failure-mode summaryAI-generated
27 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-12-15 | 1219913-2025-00219 | Malfunction | Available | exact di |
| 2025-11-12 | 1219913-2025-00205 | Malfunction | Available | exact di |
| 2025-09-15 | 1219913-2025-00168 | Malfunction | Available | exact di |
| 2025-06-27 | 1219913-2025-00125 | Malfunction | Available | exact di |
| 2025-03-25 | 1219913-2025-00058 | Malfunction | Available | exact di |
| 2025-03-21 | 1219913-2025-00056 | Malfunction | Available | exact di |
| 2025-01-15 | 1219913-2025-00020 | Malfunction | Available | exact di |
| 2024-12-02 | 1219913-2024-00484 | Malfunction | Available | exact di |
| 2024-10-24 | 1219913-2024-00451 | Malfunction | Available | exact di |
| 2024-09-07 | 1219913-2024-00402 | Malfunction | Available | exact di |
| 2023-11-17 | 1219913-2023-00293 | Malfunction | Available | exact di |
| 2023-03-15 | 1219913-2023-00049 | Malfunction | Available | exact di |
| 2023-03-06 | 1219913-2023-00044 | Malfunction | Available | exact di |
| 2022-10-21 | 1219913-2022-00349 | Malfunction | Available | exact di |
| 2022-04-07 | 1219913-2022-00104 | Malfunction | Available | exact di |
Showing 1–15 of 27
Regulatory clearances
Predicate lineage
K925277
Cited as predicate by: K172322
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-02-26 | NAI | No action indicated | Siemens Healthcare Diagnostics Products Ltd. | 0 |
| 2024-05-24 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2024-05-24 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2022-03-30 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2022-03-30 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2022-03-08 | VAI | Voluntary action indicated | Siemens Healthcare Diagnostics, Inc. | 2 |
| 2022-03-08 | VAI | Voluntary action indicated | Siemens Healthcare Diagnostics, Inc. | 2 |
| 2021-08-19 | NAI | No action indicated | Siemens Healthcare Diagnostics Inc | 0 |
| 2021-08-19 | NAI | No action indicated | Siemens Healthcare Diagnostics Inc | 0 |
| 2021-03-12 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2021-03-12 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2019-03-18 | NAI | No action indicated | Siemens Healthcare Diagnostics Inc. | 0 |
| 2018-05-24 | NAI | No action indicated | Siemens Healthcare Diagnostics Manufacturing Limited | 0 |
| 2018-03-02 | VAI | Voluntary action indicated | Siemens Healthcare Diagnostics, Inc. | 4 |
| 2018-03-02 | VAI | Voluntary action indicated | Siemens Healthcare Diagnostics, Inc. | 4 |
| 2017-11-29 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2017-11-29 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2017-11-09 | NAI | No action indicated | Siemens Healthcare Diagnostics Inc | 0 |
| 2017-09-26 | NAI | No action indicated | Siemens Healthcare Diagnostics Inc. | 0 |
| 2017-08-25 | NAI | No action indicated | Siemens Healthcare Diagnostics Inc. | 0 |
| 2012-06-29 | WL | Warning Letter | Siemens Healthcare Diagnostics, Inc. | — |
| 2012-06-29 | WL | Warning Letter | Siemens Healthcare Diagnostics, Inc. | — |
| 2012-05-29 | WL | Warning Letter | Siemens Healthcare Diagnostics, Inc. | — |
| 2012-05-29 | WL | Warning Letter | Siemens Healthcare Diagnostics, Inc. | — |
| 2012-05-10 | WL | Warning Letter | Siemens Healthcare Diagnostics, Inc. | — |
| 2012-05-10 | WL | Warning Letter | Siemens Healthcare Diagnostics, Inc. | — |
Similar devices
- AC&C DeTec hCG Pregnancy Test Device Immunostics Company, Inc
- AIA-PACK BataHCG Calibrator Set TOSOH CORPORATION
- AIA-PACK BetaHCG Sample Diluting Solution TOSOH CORPORATION
- AIA-PACK HCG CALIBRATOR SET TOSOH CORPORATION
- AIA-PACK HCG SAMPLE DILUTING SOLUTION TOSOH CORPORATION
- AIMSTEP COMBO PREGNANCY GERMAINE LABORATORIES, INC
- AIMSTEP COMBO PREGNANCY GERMAINE LABORATORIES, INC
- AIMSTEP COMBO PREGNANCY GERMAINE LABORATORIES, INC
- AIMSTEP PREGNANCY GERMAINE LABORATORIES, INC
- AIMSTEP PREGNANCY GERMAINE LABORATORIES, INC
- AIMSTEP PREGNANCY GERMAINE LABORATORIES, INC
- AIMSTEP PREGNANCY GERMAINE LABORATORIES, INC
Select up to two to place side-by-side with this device.