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 |
|---|---|---|---|---|---|---|
| 2016-10-20 | Z-2391-2018 | Class II | Terminated | Incorrect hCG resultsDistribution: US National Distribution in the states of CA, IL, MN and RI | 295 kits | clearance family |
Regulatory clearances
- 510(k)K112101Substantially equivalent (SESE) · 2012-07-17clearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2019-02-26 | NAI | No action indicated | Lochness Medical, Inc. | 0 |
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