Device recall
Z-0295-04: POLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog…
FDA device recall · Class III · Polymedco, Inc
Key facts
| Recall number (Z-number) | Z-0295-04 |
|---|---|
| Recall event | 27874 |
| Product | POLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog No. USC300. Contents: 4 x 50 Tests. For In Vitro Diagnostic (IVD) use only. COMMON/USUAL NAME: High-Sensitive C-Reactive Protein --- CLASSIFICATION NAME: C-reactive Protein, Antigen, Antiserum. |
| Product code | DCK |
| Recalling firm | Polymedco, Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 20, 2005 |
| 510(k) numbers | K001009 |
| FEI number | 1000119795 |
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