Device recall
Z-1489-2021: VITROS Black Reference Slides CATALOG #: J02316 - Product Usage: The Black…
FDA device recall · Class II · Ortho-Clinical Diagnostics, INc.
Key facts
| Recall number (Z-number) | Z-1489-2021 |
|---|---|
| Recall event | 87649 |
| Product | VITROS Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure. |
| Recalling firm | Ortho-Clinical Diagnostics, INc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 24, 2023 |
| 510(k) numbers | K182063 |
| FEI number | 1000305840 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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