Device recall
Z-2170-2018: The PREVI Color Gram dyes are used with the PREVI Color Gram instrument to stain…
FDA device recall · Class II · BioMerieux SA
Key facts
| Recall number (Z-number) | Z-2170-2018 |
|---|---|
| Recall event | 80111 |
| Product | The PREVI Color Gram dyes are used with the PREVI Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. The PREVI Color Gram instrument sprays the PREVI Color Gram reagents onto microscope slides which have been smeared with specimens… |
| Product code | KPA |
| Recalling firm | BioMerieux SA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 23, 2020 |
| FEI number | 1000611339 |
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