Device recall
Z-1930-2009: Dimension Flex Reagent Cartridge C-Reactive Protein Extended Range (RCRP). In…
FDA device recall · Class III · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1930-2009 |
|---|---|
| Recall event | 52000 |
| Product | Dimension Flex Reagent Cartridge C-Reactive Protein Extended Range (RCRP). In vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Measurement of C-Reactive Protein is useful for the detection and evaluation of infection, tissue… |
| Product code | DCN |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 9, 2009 |
| 510(k) numbers | K003419 |
| FEI number | 2517506 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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