[Recalled] 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 — Sys
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| 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 |
|---|---|
| Brand / manufacturer | Advanced Instruments, LLC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1696-2024 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 11 March 2024 |
| EAN / barcode | 00816068021150 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.