Device recall
Z-1544-2025: GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA…
FDA device recall · Class II · Agilent Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-1544-2025 |
|---|---|
| Recall event | 96484 |
| Product | GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A). |
| Product code | PFX |
| Recalling firm | Agilent Technologies, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K163367 |
| FEI number | 2916205 |
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