Device recall
Z-0930-2014: ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc
Key facts
| Recall number (Z-number) | Z-0930-2014 |
|---|---|
| Recall event | 67021 |
| Product | ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems |
| Product code | DIP |
| Recalling firm | Siemens Healthcare Diagnostics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 18, 2016 |
| 510(k) numbers | K011393 |
| FEI number | 1219913 |
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