Device recall
Z-0053-2024: PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test…
FDA device recall · Class II · Universal Meditech Inc.
Key facts
| Recall number (Z-number) | Z-0053-2024 |
|---|---|
| Recall event | 92659 |
| Product | PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips |
| Product code | NGE |
| Recalling firm | Universal Meditech Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K110889 |
| 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