Device recall
Z-2463-2015: HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type…
FDA device recall · Class II · Hardy Diagnostics
Key facts
| Recall number (Z-number) | Z-2463-2015 |
|---|---|
| Recall event | 71804 |
| Product | HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com |
| Product code | JSO |
| Recalling firm | Hardy Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 10, 2015 |
| 510(k) numbers | K102922 |
| FEI number | 2022807 |
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