Device recall
Z-2650-2017: Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised…
FDA device recall · Class III · Medtest Holdings, Inc.
Key facts
| Recall number (Z-number) | Z-2650-2017 |
|---|---|
| Recall event | 77445 |
| Product | Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum. |
| Product code | CGS |
| Recalling firm | Medtest Holdings, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 24, 2017 |
| 510(k) numbers | K972155 |
| 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