Device recall
Z-2165-2017: Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s)…
FDA device recall · Class II · Medtest Holdings, Inc.
Key facts
| Recall number (Z-number) | Z-2165-2017 |
|---|---|
| Recall event | 77048 |
| Product | Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. |
| Product code | CFJ |
| Recalling firm | Medtest Holdings, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 2, 2017 |
| 510(k) numbers | K973589 |
| FEI number | 1827821 |
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