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.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-07-30 | Z-2337-2025 | Class II | Open, Classified | Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices.Distribution: US Nationwide distribution in the state of Georgia. | 5 kits | code info 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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