Drug recall
Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes…
FDA recall event 86383 · Class II · Siemens Healthcare Diagnostics, Inc
Key facts
| Event ID | 86383 |
|---|---|
| Recall numbers | Z-0115-2021 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc |
| Product type | Devices |
| Products | Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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. |
| Initiation date | Aug 25, 2020 |
| Report date | Oct 28, 2020 |
| Termination date | Mar 10, 2023 |
| City | East Walpole |
| State | MA |
| Country | United States |
| FEI number | 1219913 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: