Device recall
Z-2403-2016: OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the…
FDA device recall · Class I · OraSure Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-2403-2016 |
|---|---|
| Recall event | 74843 |
| Product | OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses. |
| Recalling firm | OraSure Technologies, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 10, 2017 |
| FEI number | 2528909 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
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