Device recall
Z-2768-2015: MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5…
FDA device recall · Class II · MedtestDx, Inc.
Key facts
| Recall number (Z-number) | Z-2768-2015 |
|---|---|
| Recall event | 71993 |
| Product | MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic. |
| Product code | JJY |
| Recalling firm | MedtestDx, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 23, 2016 |
| 510(k) numbers | K942458 |
| 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