Device recall
Z-0479-2009: Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the…
FDA device recall · Class III · OraSure Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-0479-2009 |
|---|---|
| Recall event | 49557 |
| Product | Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro Plate EIA kit. |
| Product code | LDJ |
| Recalling firm | OraSure Technologies, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 5, 2009 |
| 510(k) numbers | K002375 |
| FEI number | 2528909 |
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