Device recall
Z-1274-2012: IMMULITE 2500 CK-MB L5KCP --- Catalog number: L5KCP2 (200 tests), L5KCP6 (600…
FDA device recall · Class II · Siemens Healthcare Diagnostics
Key facts
| Recall number (Z-number) | Z-1274-2012 |
|---|---|
| Recall event | 61029 |
| Product | IMMULITE 2500 CK-MB L5KCP --- Catalog number: L5KCP2 (200 tests), L5KCP6 (600 tests) --- Test code: RCK Color: Orange. For in vitro diagnostic use with the IMMULITE 2500 Analyzer --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in… |
| Product code | JHX |
| Recalling firm | Siemens Healthcare Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| 510(k) numbers | K034055 |
| FEI number | 2432235 |
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