Device recall
Z-2725-2017: Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers…
FDA device recall · Class III · AMS Diagnostics, LLC
Key facts
| Recall number (Z-number) | Z-2725-2017 |
|---|---|
| Recall event | 77481 |
| Product | Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis. |
| Product code | JIX |
| Recalling firm | AMS Diagnostics, LLC |
| Recall class | Class III |
| Status | Open, Classified |
| FEI number | 3009128555 |
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