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.
2 linked reportsMalfunction 2
| 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 | 2 | 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 | 0 | 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
2 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-08-20 | Z-3185-2024 | Class II | Open, Classified | Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.Distribution: US Nationwide distribution. | 5 kits | code info di |
| 2022-05-25 | Z-1598-2022 | Class II | Open, Classified | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.Distribution: US Nationwide | a. 214 kits b. 1cs c. 53 kits d. 4 bx e. 1 KT | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-05-17 | 2027969-2023-00039 | Malfunction | Available | exact di |
| 2023-05-17 | 2027969-2023-00040 | Malfunction | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-12-10 | NAI | No action indicated | Alere San Diego Inc. | 0 |
| 2019-01-11 | VAI | Voluntary action indicated | Alere San Diego, Inc. | 2 |
| 2015-06-05 | VAI | Voluntary action indicated | Alere San Diego, Inc. | 0 |
| 2014-10-29 | NAI | No action indicated | Alere San Diego Inc. | 0 |
| 2014-06-27 | VAI | Voluntary action indicated | Alere San Diego, Inc. | 10 |
| 2012-10-10 | WL | Warning Letter | Alere San Diego, Inc. | — |
| 2012-06-27 | OAI | Official action indicated | Alere San Diego, Inc. | 7 |
| 2011-08-01 | NAI | No action indicated | Alere San Diego Inc. | 0 |
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