Device recall
Z-0094-2023: N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System…
FDA device recall · Class II · SIEMENS HEALTHCARE DIAGNOSTICS INC
Key facts
| Recall number (Z-number) | Z-0094-2023 |
|---|---|
| Recall event | 90867 |
| Product | N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299 |
| Product code | CFN |
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K083445 |
| FEI number | 3014838736 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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