Device recall
Z-0508-2013: Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc
Key facts
| Recall number (Z-number) | Z-0508-2013 |
|---|---|
| Recall event | 63682 |
| Product | Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA Centaur XP systems. This… |
| Product code | NIG |
| Recalling firm | Siemens Healthcare Diagnostics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 25, 2015 |
| 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