Device recall
Z-0258-2025: 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative…
FDA device recall · Class III · DRG International, Inc.
Key facts
| Recall number (Z-number) | Z-0258-2025 |
|---|---|
| Recall event | 95429 |
| Product | 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292 |
| Product code | JLX |
| Recalling firm | DRG International, Inc. |
| Recall class | Class III |
| Status | Open, Classified |
| FEI number | 2245285 |
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