Device recall
Z-1152-2013: VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the…
FDA device recall · Class II · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-1152-2013 |
|---|---|
| Recall event | 64707 |
| Product | VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma. |
| Product code | DLZ |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 23, 2015 |
| 510(k) numbers | K984288 |
| FEI number | 1000136573 |
At a glance
- 1–9 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