Device recall
Z-0101-2021: ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-0101-2021 |
|---|---|
| Recall event | 86504 |
| Product | ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941 |
| Product code | JIT |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K131307 |
| FEI number | 2432235 |
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