Device recall
Z-0921-2012: Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method. Catalog Number…
FDA device recall · Class II · Catch Incorporated
Key facts
| Recall number (Z-number) | Z-0921-2012 |
|---|---|
| Recall event | 60811 |
| Product | Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method. Catalog Number E02-057-02. A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serum or plasma. Homocysteine measurements are used in the diagnosis and treatment of… |
| Product code | LPS |
| Recalling firm | Catch Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 2012 |
| FEI number | 3005002431 |
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