Device recall
Z-2457-2008: Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The…
FDA device recall · Class III · Cholestech Corp
Key facts
| Recall number (Z-number) | Z-2457-2008 |
|---|---|
| Recall event | 49142 |
| Product | Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum. Measurement of CRP is useful as an aid in the… |
| Product code | DCK |
| Recalling firm | Cholestech Corp |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 30, 2009 |
| 510(k) numbers | K040579 |
| FEI number | 1000123985 |
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