Class 2 Device Recall OsmoPRO MAX Automated Osmometer

• Date Initiated by Firm: March 11, 2024
• Date Posted: April 29, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1696-2024
• Recall Event ID: 94330
• Product Classification: Osmometer for clinical use - Product Code JJM
• 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
• Code Information: UDI-DI: 00816068021150; Serial Numbers: 23030208A, 23050414A, 23050417A, 23010059A, 23040283A, 23010014A, 23020166A, 23040284A, 23020159A, 23050410A, 23030236A, 23020165A, 23020156A, 23020161A, 23030239A, 23030210A, 23030233A, 23030232A, 23020158A, 23030206A, 22111360A, 23020155A, 23030209A, 23040287A, 22111362A, 23020160A, 23040288A, 23010052A, 22111354A, 23010055A, 22111350A, 22111365A, 23010053A, 22111363A, 23030237A, 23010062A, 23010015A, 23030202A, 23030207A, 23040290A, 23030204A, 23020157A, 22111367A, 23020158A, 23030203A, 23030240A, 22111358A, 22111359A, 23040286A, 22111355A, 23030205A, 23020164A, 22111368A, 23030238A, 23010060A, 23010061A, 23020163A, 23010011A22111364A. All serial numbers that end in A
• Recalling Firm/ Manufacturer: Advanced Instruments, LLC; 2 Technology Way; Norwood MA 02062-2633
• For Additional Information Contact: Tech Service; +1-800-2254034
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: 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 TechService@aicompanies.com. 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.
• Quantity in Commerce: 58 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, France, Germany, Iceland, Netherlands, South Korea, Spain, Switzerland, Taiwan.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.