Device recall
Z-2475-2019: Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the…
FDA device recall · Class II · Alere San Diego, Inc.
Key facts
| Recall number (Z-number) | Z-2475-2019 |
|---|---|
| Recall event | 83410 |
| Product | Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Cholestech LDX System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The Lipid Profile GLU… |
| Product code | JJE |
| Recalling firm | Alere San Diego, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 12, 2023 |
| 510(k) numbers | K120615 |
| FEI number | 1000125596 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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