Device recall
Z-2409-2012: ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number…
FDA device recall · Class III · Siemens Healthcare Diagnostics, Inc
Key facts
| Recall number (Z-number) | Z-2409-2012 |
|---|---|
| Recall event | 62897 |
| Product | ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in vitro diagnostic use in the… |
| Product code | CFT |
| Recalling firm | Siemens Healthcare Diagnostics, Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 26, 2014 |
| 510(k) numbers | K904714 |
| FEI number | 1219913 |
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