Device recall
Z-1538-2020: ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1538-2020 |
|---|---|
| Recall event | 85037 |
| Product | ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA Chemistry systems. Such measurements are useful in the… |
| Product code | JFM |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 23, 2021 |
| 510(k) numbers | K053132 |
| FEI number | 2517506 |
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