Device recall
Z-1117-2012: VITROS Chemistry Products PHBR Slides, REF 822 1384 --- COMMON/USUAL NAME…
FDA device recall · Class II · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-1117-2012 |
|---|---|
| Recall event | 60831 |
| Product | VITROS Chemistry Products PHBR Slides, REF 822 1384 --- COMMON/USUAL NAME: VITROS PHBR (Phenobarbital) Slides --- Ortho-Clinical Diagnostics, Inc. Rochester, NY --- Ortho-Clinical Diagnostics High Wycombe, UK --- This is an in vitro diagnostic. For in vitro diagnostic use only. VITROS Chemistry… |
| Product code | DLZ |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 10, 2016 |
| 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