Advanced Instruments, LLC: Medical Device Recall in 2024 - (Recall #: Z-1696-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: March 11, 2024

Date Posted: May 8, 2024

Recall Number: Z-1696-2024

Event ID: 94330

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.

Status: Ongoing

Product Quantity: 58 units

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

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, France, Germany, Iceland, Netherlands, South Korea, Spain, Switzerland, Taiwan.

Voluntary or Mandated:

Voluntary: Firm initiated