Device recall
Z-2713-2026: GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic…
FDA device recall · Class II · WALLAC OY
Key facts
| Recall number (Z-number) | Z-2713-2026 |
|---|---|
| Recall event | 99065 |
| Product | GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE. |
| Product code | KQP |
| Recalling firm | WALLAC OY |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K100101 |
| FEI number | 3002808498 |
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