Device recall
Z-0632-2013: ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a…
FDA device recall · Class II · Horiba Instruments, Inc dba Horiba Medical
Key facts
| Recall number (Z-number) | Z-0632-2013 |
|---|---|
| Recall event | 63838 |
| Product | ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry. |
| Product code | CIT |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 12, 2013 |
| 510(k) numbers | K060318 |
| 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