Device recall
Z-0739-2016: ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the…
FDA device recall · Class II · Horiba Instruments Inc
Key facts
| Recall number (Z-number) | Z-0739-2016 |
|---|---|
| Recall event | 73033 |
| Product | ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on an enzymatic method of using a multi-step approach ending with a photometric end-point reaction. |
| Product code | CGX |
| Recalling firm | Horiba Instruments Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 7, 2016 |
| 510(k) numbers | K110137 |
| 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