Device recall
Z-2877-2020: Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate…
FDA device recall · Class III · OraSure Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-2877-2020 |
|---|---|
| Recall event | 86122 |
| Product | Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT |
| Product code | JXM |
| Recalling firm | OraSure Technologies, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 8, 2021 |
| 510(k) numbers | K013882 |
| FEI number | 3004142665 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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