Device recall
Z-0738-2016: The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for…
FDA device recall · Class II · Horiba Instruments Inc
Key facts
| Recall number (Z-number) | Z-0738-2016 |
|---|---|
| Recall event | 73033 |
| Product | The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with… |
| Product code | CHH |
| Recalling firm | Horiba Instruments Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 7, 2016 |
| 510(k) numbers | K060854 |
| FEI number | 3002698356 |
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