Device recall
Z-0453-05: OTC Pregnancy Test Kit labeled: ''CHOICE Pregnancy Test Kit'' (PA-320)…
FDA device recall · Class II · International Chemical Inc.
Key facts
| Recall number (Z-number) | Z-0453-05 |
|---|---|
| Recall event | 30794 |
| Product | OTC Pregnancy Test Kit labeled: ''CHOICE Pregnancy Test Kit'' (PA-320) , cassette type with cup and dropper. Label states: ''Easy to Use, Easy Reading, Positive result as early as 1 minute, Over 99% accurate.'' Each box contains one home test kit. Responsible firm on label: Distributed by: ICC… |
| Product code | LCX |
| Recalling firm | International Chemical Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 13, 2005 |
| FEI number | 1319423 |
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