Device recall
Z-2778-2016: LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in…
FDA device recall · Class III · Alere San Diego, Inc.
Key facts
| Recall number (Z-number) | Z-2778-2016 |
|---|---|
| Recall event | 74940 |
| Product | LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. Product Usage: The Optics Check Cassette is used to check the optics system of the Alere Cholestech LDX Analyzer. It is run once a… |
| Product code | LBS |
| Recalling firm | Alere San Diego, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 28, 2016 |
| 510(k) numbers | K120615 |
| FEI number | 1000125596 |
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