Device recall
Z-0747-2013: Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770…
FDA device recall · Class III · Alere San Diego, Inc.
Key facts
| Recall number (Z-number) | Z-0747-2013 |
|---|---|
| Recall event | 63918 |
| Product | Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and… |
| Product code | JJY |
| Recalling firm | Alere San Diego, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 26, 2013 |
| 510(k) numbers | K102700 |
| FEI number | 1000125596 |
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