Device recall
Z-2306-2012: Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc…
FDA device recall · Class II · Princeton Biomeditech Corp
Key facts
| Recall number (Z-number) | Z-2306-2012 |
|---|---|
| Recall event | 62537 |
| Product | Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. 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 swab, nasopharyngeal swab and nasal pharyngeal… |
| 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