Device recall
Z-0984-2012: VITROS Valproic Acid (VALP) Reagent, REF/Catalog No. 6801710 --- Ortho- Clinical…
FDA device recall · Class II · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-0984-2012 |
|---|---|
| Recall event | 60800 |
| Product | VITROS Valproic Acid (VALP) Reagent, REF/Catalog No. 6801710 --- Ortho- Clinical Diagnostics Rochester, NY USA -- Ortho- Clinical Diagnostics High Wycombe, UK --- An in vitro diagnostic. For in vitro diagnostic use only. Used to quantitatively measure valproic acid (VALP) concentration in human… |
| Product code | LEG |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 12, 2016 |
| 510(k) numbers | K042476 |
| 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