Device recall
Z-0055-2024: PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS
FDA device recall · Class II · Universal Meditech Inc.
Key facts
| Recall number (Z-number) | Z-0055-2024 |
|---|---|
| Recall event | 92659 |
| Product | PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS |
| Product code | LCX |
| Recalling firm | Universal Meditech Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K974059 |
| FEI number | 3011908678 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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