Device recall
Z-0191-2018: SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T…
FDA device recall · Class II · CSL Behring GmbH
Key facts
| Recall number (Z-number) | Z-0191-2018 |
|---|---|
| Recall event | 77515 |
| Product | SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089 (High); |
| Product code | CHN |
| Recalling firm | CSL Behring GmbH |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 7, 2020 |
| 510(k) numbers | K052788 |
| FEI number | 3003098680 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database