Device recall
Z-0461-2012: SPOT-Light" HER2 CISH Kit, catalog #84-0150, 20 tests/kit, labeled in part…
FDA device recall · Class II · Life Technologies Corporation
Key facts
| Recall number (Z-number) | Z-0461-2012 |
|---|---|
| Recall event | 60542 |
| Product | SPOT-Light" HER2 CISH Kit, catalog #84-0150, 20 tests/kit, labeled in part ***Invitrogen Corporation 7335 Executive Way Frederick MD 21704 www.invitrogen.com*** Product Usage: The SPOT-Light HER2 CISH Kit is intended to quantitatively determine HER2 gene amplification in formalin-fixed… |
| Product code | NYQ |
| Recalling firm | Life Technologies Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 10, 2012 |
| PMA numbers | P050040 |
| FEI number | 3003335080 |
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