NCWClass II

System, Test, Her-2/neu, Monitoring

Immunology · 21 CFR 866.6010

MDR events0All time

Recalls1All time

Registered firms3Currently listed

510(k) clearances3All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

1 recall events for this product code

Siemens Healthcare Diagnostics, Inc
TerminatedUnknown
Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes:
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 negative results.
Z-0115-2021 · View FDA record ↗

Registered firms

3 firms currently registered for this product code

510(k) clearances

3 clearances for this product code