Device recall
Z-1970-2013: ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. #…
FDA device recall · Class III · Siemens Healthcare Diagnostics, Inc
Key facts
| Recall number (Z-number) | Z-1970-2013 |
|---|---|
| Recall event | 65626 |
| Product | ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3, T3, T4, Tup, FT4, THEO2. |
| Product code | JIS |
| Recalling firm | Siemens Healthcare Diagnostics, Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 25, 2014 |
| 510(k) numbers | K961510 |
| 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