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Atellica IM H2n
Siemens Healthcare Diagnostics Inc. · Model 10995591 · UDI-DI 00630414599151
1
510(k) clearances
0
Adverse events
1
Recalls
3
Facilities
Description
Her-2/neu (H2n) Atellica IM - RGT 50T
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 positive or false n |
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