Device recall
Z-2273-2016: VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique…
FDA device recall · Class II · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-2273-2016 |
|---|---|
| Recall event | 74355 |
| Product | VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales Unit: 300 slides/pack Product Usage: For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum… |
| Product code | CJY |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 8, 2018 |
| 510(k) numbers | K072440 |
| FEI number | 1000305840 |
At a glance
- 1–9 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