Device recall
Z-0469-2007: Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, Product Code…
FDA device recall · Class III · Mizuho USA, Inc.
Key facts
| Recall number (Z-number) | Z-0469-2007 |
|---|---|
| Recall event | 36898 |
| Product | Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, Product Code 30136 and Confirm Clearly Refills Kits, Product Code 30138) Note: (1) Confirm Clearly Starter Kits: When sold in the U.S., the product consists of a reader and two disposable test sticks; when sold in Canada, the… |
| Product code | LCX |
| Recalling firm | Mizuho USA, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 23, 2008 |
| 510(k) numbers | K060825 |
| FEI number | 1000150264 |
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