Device recall
Z-2280-2013: ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role…
FDA device recall · Class III · Horiba Instruments, Inc dba Horiba Medical
Key facts
| Recall number (Z-number) | Z-2280-2013 |
|---|---|
| Recall event | 66209 |
| Product | ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium is present in plasma in… |
| Product code | CIC |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 23, 2014 |
| 510(k) numbers | K070249 |
| 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