Device recall
Z-1186-2012: ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) Cat. Nos. 100 Test kit…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc
Key facts
| Recall number (Z-number) | Z-1186-2012 |
|---|---|
| Recall event | 60321 |
| Product | ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) Cat. Nos. 100 Test kit 04385983 (129501) 500 Test kit 06587575 (129502). For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (PTH) in EDTA plasma or serum using the ADVIA Centaur systems. This assay is… |
| Product code | CEW |
| Recalling firm | Siemens Healthcare Diagnostics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 8, 2012 |
| 510(k) numbers | K020217 |
| 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