Device recall
Z-0845-2021: VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD…
FDA device recall · Class II · Ortho Clinical Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-0845-2021 |
|---|---|
| Recall event | 87019 |
| Product | VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293 |
| Product code | CEK |
| Recalling firm | Ortho Clinical Diagnostics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 27, 2021 |
| FEI number | 2250051 |
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