Device recall
Z-1842-2015: VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The…
FDA device recall · Class II · Remel Inc
Key facts
| Recall number (Z-number) | Z-1842-2015 |
|---|---|
| Recall event | 71291 |
| Product | VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids. |
| Product code | MDB |
| Recalling firm | Remel Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 24, 2017 |
| FEI number | 1924669 |
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