Device recall
Z-0296-04: POLYMEDCO ULTRA-CRP LATEX ENHANCED ASSAY, Catalog No. CPU400. Contents: 1 x 50…
FDA device recall · Class III · Polymedco, Inc
Key facts
| Recall number (Z-number) | Z-0296-04 |
|---|---|
| Recall event | 27874 |
| Product | POLYMEDCO ULTRA-CRP LATEX ENHANCED ASSAY, Catalog No. CPU400. Contents: 1 x 50 ML R1, 2 x 6 ML R2. R1 is the HIGH SENSITIVE CRP Buffer IVD (50 ml). R2 is the HIGH SENSITIVE CRP Latex IVD (6 ml). For In Vitro Diagnostic (IVD) use only. COMMON/USUAL NAME: High-Sensitive C-Reactive Protein… |
| 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