Device recall
Z-0743-2016: ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the…
FDA device recall · Class II · Horiba Instruments Inc
Key facts
| Recall number (Z-number) | Z-0743-2016 |
|---|---|
| Recall event | 73033 |
| Product | ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). |
| Product code | KNK |
| Recalling firm | Horiba Instruments Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 7, 2016 |
| 510(k) numbers | K081276 |
| 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