Device recall
Z-0417-2015: MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components…
FDA device recall · Class II · Diagnostic Hybrids Inc
Key facts
| Recall number (Z-number) | Z-0417-2015 |
|---|---|
| Recall event | 69545 |
| Product | MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic. |
| Product code | JZH |
| Recalling firm | Diagnostic Hybrids Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 3, 2015 |
| FEI number | 1000122536 |
At a glance
- None 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