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

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.

Advanced Instruments issued Urgent Medical Device Recall Letter on 3/11/24 via email. Letter states reason for recall, health risk and action to take: 1. Discontinue use of your device. 2. Advanced Instruments will contact you regarding the return and exchange of your Device. Several solutions are available as needed to ensure continuity of testing. 3. For those users whose lab protocol requires the review of previous data, Advanced Instruments is available to review the data. 4. Complete and return the attached acknowledgement form. Advanced Instruments is implementing permanent corrective actions to address the two issues described and as part of the process above you will be provided with information on the next steps to implement a solution for impacted devices. If you need any further information or support concerning this issue, please contact [email protected]. To better assist you, please have your instrument serial number ready. 1-800-225-4034 (Toll Free US & Canada) Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.