Device recall
Z-0259-2025: Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of…
FDA device recall · Class II · Princeton Biomeditech Corp
Key facts
| Recall number (Z-number) | Z-0259-2025 |
|---|---|
| Recall event | 95439 |
| Product | Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Model/Catalog Number: 1004 |
| Product code | JHI |
| Recalling firm | Princeton Biomeditech Corp |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K944426 |
| FEI number | 2246703 |
At a glance
- 1–9 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