Device recall
Z-0217-2007: Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP…
FDA device recall · Class III · Biogenex Laboratories
Key facts
| Recall number (Z-number) | Z-0217-2007 |
|---|---|
| Recall event | 36514 |
| Product | Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit containing reagent vials, Bio-Genex, San Ramon, CA. |
| Product code | NJT |
| Recalling firm | Biogenex Laboratories |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 4, 2007 |
| FEI number | 2936532 |
At a glance
- None 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