Device recall
Z-1478-2013: Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a…
FDA device recall · Class III · Bion Enterprises Ltd
Key facts
| Recall number (Z-number) | Z-1478-2013 |
|---|---|
| Recall event | 64164 |
| Product | Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits |
| Product code | GQH |
| Recalling firm | Bion Enterprises Ltd |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 5, 2015 |
| 510(k) numbers | K880679 |
| FEI number | 1419968 |
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