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Unyvero
Curetis GmbH · Model L4 Lysator · UDI-DI 04260364750010
QBH
Prescription
2
510(k) clearances
0
Adverse events
4
Recalls
2
Facilities
Description
Instrument to pre-process up to 4 samples for Unyvero Cartridges
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-14 | BioFire Diagnostics, LLC | Their is a potential for false positive results when using Pneumonia panel. |
| 2023-05-08 | BioFire Diagnostics, LLC | Due to manufacturing issue, panels may result in false negative results. |
| 2021-06-07 | BioFire Diagnostics, LLC | Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame. |
| 2021-04-16 | BioFire Diagnostics, LLC | Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process. |
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