Device recall
Z-0003-2008: BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in…
FDA device recall · Class II · Meretek Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-0003-2008 |
|---|---|
| Recall event | 38430 |
| Product | BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek Diagnostics, Inc., Lafayette, CO. |
| Product code | MSQ |
| Recalling firm | Meretek Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 26, 2007 |
| 510(k) numbers | K014225 |
| FEI number | 3000210499 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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