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VENTANA CLDN18 (43-14A) RxDx Assay
Ventana Medical Systems, Inc. · Model 08287066001 · UDI-DI 07613336149201
QJZ
Prescription
0
510(k) clearances
505
Adverse events (27 deaths)
2
Recalls
8
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-08 | Fresenius Medical Care Holdings, Inc. | Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) techn |
| 2021-12-07 | Fresenius Medical Care Holdings, Inc. | Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is i |
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