Device recall
Z-0612-2017: ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc
Key facts
| Recall number (Z-number) | Z-0612-2017 |
|---|---|
| Recall event | 75523 |
| Product | ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491379 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated… |
| Product code | NIG |
| Recalling firm | Siemens Healthcare Diagnostics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 2, 2023 |
| 510(k) numbers | K031393 |
| 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