Device recall
Z-1418-2017: ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc
Key facts
| Recall number (Z-number) | Z-1418-2017 |
|---|---|
| Recall event | 76212 |
| Product | ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension VistaSystem. Progesterone measurements are used in the diagnosis and… |
| Product code | JLS |
| Recalling firm | Siemens Healthcare Diagnostics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 18, 2019 |
| 510(k) numbers | K932955 |
| 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