Device recall
Z-1696-2024: OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method…
FDA device recall · Class II · Advanced Instruments, LLC
Key facts
| Recall number (Z-number) | Z-1696-2024 |
|---|---|
| Recall event | 94330 |
| Product | OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serum, plasma, and urine. Model/Catalog Number: OsmoPRO MAX Software Version: 1.5.0.0 |
| Product code | JJM |
| Recalling firm | Advanced Instruments, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1217058 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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