Device recall
Z-0289-2013: ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot…
FDA device recall · Class III · Horiba Instruments, Inc dba Horiba Medical
Key facts
| Recall number (Z-number) | Z-0289-2013 |
|---|---|
| Recall event | 63536 |
| Product | ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic… |
| Product code | CGX |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 29, 2012 |
| 510(k) numbers | K072115 |
| 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