Drug recall
OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression…
FDA recall event 94330 · Class II · Advanced Instruments, LLC
Key facts
| Event ID | 94330 |
|---|---|
| Recall numbers | Z-1696-2024 |
| Recalling firm | Advanced Instruments, LLC |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls. |
| Initiation date | Mar 11, 2024 |
| Report date | May 8, 2024 |
| City | Norwood |
| State | MA |
| Country | United States |
| FEI number | 1217058 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: