Device recall
Z-1941-2014: illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10…
FDA device recall · Class II · Meridian Bioscience Inc
Key facts
| Recall number (Z-number) | Z-1941-2014 |
|---|---|
| Recall event | 68396 |
| Product | illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions. |
| Product code | OMN |
| Recalling firm | Meridian Bioscience Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 30, 2014 |
| 510(k) numbers | K110012 |
| FEI number | 1524213 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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