Device recall
Z-2764-2015: Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or…
FDA device recall · Class III · Pointe Scientific, Inc.
Key facts
| Recall number (Z-number) | Z-2764-2015 |
|---|---|
| Recall event | 71953 |
| Product | Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits: HDPE plastic bottle, PP… |
| Product code | LBR |
| Recalling firm | Pointe Scientific, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 29, 2015 |
| 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