Device recall
Z-2666-2016: Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The…
FDA device recall · Class II · Tecan US, Inc.
Key facts
| Recall number (Z-number) | Z-2666-2016 |
|---|---|
| Recall event | 74806 |
| Product | Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily in in-vitro diagnostic processing of samples from the human body to obtain information on physiological and pathological states. Software and instrument have been validated for… |
| Product code | LXG |
| Recalling firm | Tecan US, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 23, 2017 |
| FEI number | 1037985 |
At a glance
- None 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