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System, Test, Her-2/Neu, Monitoring
FDA product code NCW · Class 2 · Immunology
6
Registered devices
0
Adverse events
1
Recalls
3
510(k) clearances
Devices with this code
Atellica IM H2n Calibrator — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® H2n QC — Siemens Healthcare Diagnostics Inc.Atellica IM H2n QC — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® H2n Calibrator — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® H2n — Siemens Healthcare Diagnostics Inc.Atellica IM H2n — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-08-25 | Siemens Healthcare Diagnostics, Inc | Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IFU) was no longer achieved. This can potentially result in false |
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