Device recall
Z-1514-2020: IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1514-2020 |
|---|---|
| Recall event | 84947 |
| Product | IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 tests), L2KE26 (600 tests) - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in serum, as an aid in the… |
| Product code | CHP |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 18, 2021 |
| FEI number | 2432235 |
At a glance
- None 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