Device recall
Z-0530-2009: f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL…
FDA device recall · Class II · Mainline Technology, Inc.
Key facts
| Recall number (Z-number) | Z-0530-2009 |
|---|---|
| Recall event | 49100 |
| Product | f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL; Catalog # 43065. |
| Product code | JHI |
| Recalling firm | Mainline Technology, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 7, 2011 |
| FEI number | 1000160426 |
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