Device recall
Z-1271-2012: IMMULITE/IMMULITE 1000 CK-MB LKMB --- Catalog number: LKMB1 (100 tests), LKMB5…
FDA device recall · Class II · Siemens Healthcare Diagnostics
Key facts
| Recall number (Z-number) | Z-1271-2012 |
|---|---|
| Recall event | 61029 |
| Product | IMMULITE/IMMULITE 1000 CK-MB LKMB --- Catalog number: LKMB1 (100 tests), LKMB5 (500 tests) --- Test code: CMB Color: Dark Blue. For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma… |
| Product code | JHX |
| Recalling firm | Siemens Healthcare Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| 510(k) numbers | K004002 |
| 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