Device recall
Z-0968-2010: OvuChek Saliva Ovulation Disposable Test Strips; 5 disposable test strips per…
FDA device recall · Class II · Quest Products Inc.
Key facts
| Recall number (Z-number) | Z-0968-2010 |
|---|---|
| Recall event | 52901 |
| Product | OvuChek Saliva Ovulation Disposable Test Strips; 5 disposable test strips per pouch, packaged in a box with a specimen cup and instructions for use, 12 boxes per case; a rapid colorimetric indicator for the qualitative changes (ferning) of salt content in saliva to aid in the prediction of… |
| Product code | NGE |
| Recalling firm | Quest Products Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 3, 2010 |
| FEI number | 3005857009 |
At a glance
- None 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