Device recall
Z-2307-2012: Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road…
FDA device recall · Class II · Princeton Biomeditech Corp
Key facts
| Recall number (Z-number) | Z-2307-2012 |
|---|---|
| Recall event | 62537 |
| Product | Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-739-5890. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal… |
| Product code | GNX |
| Recalling firm | Princeton Biomeditech Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 14, 2014 |
| 510(k) numbers | K083746 |
| FEI number | 2246703 |
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