Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses Recalled by Advanced Instruments, LLC Due to System error messages may delay the ability to...

Date: March 11, 2024
Company: Advanced Instruments, LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Advanced Instruments, LLC directly.

Affected 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 Software Version: 1.5.0.0

Quantity: 58 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Advanced Instruments, LLC

Advanced Instruments, LLC has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report