Device recall
Z-1911-2016: Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph…
FDA device recall · Class II · Integrated Science Systems Inc
Key facts
| Recall number (Z-number) | Z-1911-2016 |
|---|---|
| Recall event | 74140 |
| Product | Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture |
| Product code | LHJ |
| Recalling firm | Integrated Science Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 28, 2017 |
| FEI number | 3011450093 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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