Device recall
Z-2427-2008: Mainline Confirms Strep A, Group A Streptococcus; A rapid one-step visual test…
FDA device recall · Class II · Mainline Technology, Inc.
Key facts
| Recall number (Z-number) | Z-2427-2008 |
|---|---|
| Recall event | 49082 |
| Product | Mainline Confirms Strep A, Group A Streptococcus; A rapid one-step visual test for the detection of group A streptococcal antigen directly from throat swabs, Mainline Technology, Inc., Ann Arbor, MI; Cat. Nos. 3030-20 (20 test) and 3030-40 (40 test). |
| Product code | GTY |
| Recalling firm | Mainline Technology, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 16, 2009 |
| FEI number | 1000160426 |
At a glance
- None 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