Device recall
Z-1509-2016: OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming…
FDA device recall · Class III · OraSure Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-1509-2016 |
|---|---|
| Recall event | 73643 |
| Product | OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device. |
| Product code | MZO |
| Recalling firm | OraSure Technologies, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 7, 2018 |
| PMA numbers | P080027 |
| FEI number | 2528909 |
At a glance
- None 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