Device recall
Z-1684-2025: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens…
FDA device recall · Class II · Siemens Healthcare Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-1684-2025 |
|---|---|
| Recall event | 96539 |
| Product | epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n. |
| Product code | CHL |
| Recalling firm | Siemens Healthcare Diagnostics Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K200107 |
| FEI number | 3002637618 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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