Device recall
Z-0448-2009: Homocysteine Reagent Test Kit. The Homocysteine test kits were manufactured…
FDA device recall · Class II · Catch Incorporated
Key facts
| Recall number (Z-number) | Z-0448-2009 |
|---|---|
| Recall event | 48734 |
| Product | Homocysteine Reagent Test Kit. The Homocysteine test kits were manufactured under 2 brand names. The first brand name Catch, the label reads "CATCH Catch Inc., Bothell, WA 98011 HOMOCYSTEINE REAGENT KIT, Catalog Number A11167, 100 Test Kit, Manufactured at Intersect Systems, Inc., Longview, WA… |
| Product code | LPS |
| Recalling firm | Catch Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 28, 2010 |
| 510(k) numbers | K011689 |
| FEI number | 3005002431 |
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