Device recall
Z-2966-2026: Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen…
FDA device recall · Class II · Siemens Healthcare Diagnostics Products Ltd.
Key facts
| Recall number (Z-number) | Z-2966-2026 |
|---|---|
| Recall event | 99447 |
| Product | Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly |
| Product code | LIP |
| Recalling firm | Siemens Healthcare Diagnostics Products Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K091361 |
| FEI number | 3002806944 |
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