Device recall
Z-2171-2018: Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and…
FDA device recall · Class II · BioMerieux SA
Key facts
| Recall number (Z-number) | Z-2171-2018 |
|---|---|
| Recall event | 80111 |
| Product | Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining… |
| Product code | JTS |
| 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
- 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