Device recall
Z-2063-2016: Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative…
FDA device recall · Class II · Medtest Holdings, Inc.
Key facts
| Recall number (Z-number) | Z-2063-2016 |
|---|---|
| Recall event | 74234 |
| Product | Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2. |
| Product code | LPS |
| Recalling firm | Medtest Holdings, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 5, 2016 |
| 510(k) numbers | K083222 |
| FEI number | 1827821 |
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