Device recall
Z-0971-03: Neonatal Total Galactose Test Kit, Item #NG-1000E, Filter #2992, contents for…
FDA device recall · Class III · PerkinElmer Life Sciences Inc
Key facts
| Recall number (Z-number) | Z-0971-03 |
|---|---|
| Recall event | 26412 |
| Product | Neonatal Total Galactose Test Kit, Item #NG-1000E, Filter #2992, contents for 960 assays. |
| Product code | JIA |
| Recalling firm | PerkinElmer Life Sciences Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 24, 2008 |
| 510(k) numbers | K950481 |
| FEI number | 1522510 |
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