Device recall
Z-2316-2017: MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2…
FDA device recall · Class III · Medtest Holdings, Inc.
Key facts
| Recall number (Z-number) | Z-2316-2017 |
|---|---|
| Recall event | 77062 |
| Product | MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green plastic screw cap. " 1 0… |
| Product code | JJY |
| Recalling firm | Medtest Holdings, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 17, 2017 |
| 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