Device recall
Z-0389-2019: Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL…
FDA device recall · Class III · Medtest Holdings, Inc.
Key facts
| Recall number (Z-number) | Z-0389-2019 |
|---|---|
| Recall event | 81160 |
| Product | Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only. |
| Product code | LBR |
| Recalling firm | Medtest Holdings, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 4, 2019 |
| 510(k) numbers | K992002 |
| FEI number | 1827821 |
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