Device recall
Z-0119-2020: Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF…
FDA device recall · Class II · Horiba Instruments Incorporated
Key facts
| Recall number (Z-number) | Z-0119-2020 |
|---|---|
| Recall event | 83701 |
| Product | Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944 |
| Product code | CHI |
| Recalling firm | Horiba Instruments Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 16, 2020 |
| FEI number | 2086725 |
At a glance
- None 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