BEUDAMED
    FDA Enforcement Class II Ongoing

    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: Z-1696-2024 · Reported May 8, 2024

    Enforcement

    Recall Number
    Z-1696-2024
    Event ID
    94330
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Advanced Instruments, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 8, 2024
    Initiation Date
    March 11, 2024
    Classification Date
    April 29, 2024
    Address
    2 Technology Way, Norwood, MA, 02062-2633, United States

    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

    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.

    Code Info

    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

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

    Quantity

    58 units