FDA Medical Device Recalls (openFDA)
Advanced Instruments, LLC: 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
- Recall number
- Z-1696-2024
- Recalling firm
- Advanced Instruments, LLC
- 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
- Status
- Open, Classified
- Initiated
- 2024-03-11
- Posted
- 2024-04-29
- Terminated
- not on file
- Reason
- 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.
- Root 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
- 58 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, France, Germany, Iceland, Netherlands, South Korea, Spain, Switzerland, Taiwan.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJM
- Firm FEI
- 1217058
- Firm city
- Norwood
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28