# FDA recall Z-1696-2024

> **Advanced Instruments, LLC** · Class II · device recall initiated 2024-03-11.

## 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

## 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.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic,  France, Germany, Iceland, Netherlands, South Korea, Spain, Switzerland, Taiwan.

## Key facts

- **Recall number:** Z-1696-2024
- **Recalling firm:** Advanced Instruments, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-11
- **Report date:** 2024-05-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norwood, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1696-2024

## Citation

> AI Analytics. FDA recall Z-1696-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1696-2024. Source: US FDA. Licensed CC0.

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