Z-1696-2024Class II

OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression...

Name: Z-1696-2024 OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression...
Creator: Advanced Instruments, LLC
Published: 2024-03-11
License: https://open.fda.gov/license/

Advanced Instruments, LLC / initiated 2024-03-11 / Open, Classified / root cause: manufacturing process

FDA source

Advanced Instruments, LLC began a recall of OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serum, plasma, and... on 2024-03-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1696-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-11
Posted: 2024-04-29
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
Product code: JJM Osmometer For Clinical Use
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.
Root cause tag: manufacturing process
FDA 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 [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.
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1696-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1696-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-04-29

Product code JJM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)