Device recall
Z-0470-2016: FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious…
FDA device recall · Class II · Hardy Diagnostics
Key facts
| Recall number (Z-number) | Z-0470-2016 |
|---|---|
| Recall event | 72786 |
| Product | FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens. |
| Product code | JSC |
| Recalling firm | Hardy Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 28, 2016 |
| FEI number | 2022807 |
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