Device recall
Z-0229-2015: ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative…
FDA device recall · Class III · Siemens Healthcare Diagnostics, Inc
Key facts
| Recall number (Z-number) | Z-0229-2015 |
|---|---|
| Recall event | 69461 |
| Product | ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test) |
| Product code | NBC |
| Recalling firm | Siemens Healthcare Diagnostics, Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 22, 2015 |
| 510(k) numbers | K031038 |
| 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