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 |
|---|---|---|---|---|---|---|
| 2019-05-10 | Z-1907-2019 | Class II | Terminated | Potential for reporting low assay resultsDistribution: US Nationwide n the states of NJ, NY, MI, WV, TX including PR | 30 kits | clearance family |
Regulatory clearances
- 510(k)K102673Substantially equivalent (SESE) · 2011-09-30clearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2013-11-21 | NAI | No action indicated | Phadia GmbH | 0 |
| 2011-08-18 | NAI | No action indicated | Phadia Ab | 0 |
| 2011-08-18 | NAI | No action indicated | Phadia Ab | 0 |
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