Device recall
Z-0859-2010: Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol…
FDA device recall · Class II · Pointe Scientific, Inc.
Key facts
| Recall number (Z-number) | Z-0859-2010 |
|---|---|
| Recall event | 53810 |
| Product | Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # H7511-60 and Catalog # H7511-SAM. HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; . (Clinical chemistry). For the quantitative determination of high… |
| Product code | LBR |
| Recalling firm | Pointe Scientific, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 11, 2011 |
| 510(k) numbers | K812574 |
| 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