OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure
Summary
The FDA issued a Class II for OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method by Advanced Instruments, LLC. 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 wh.
Details
Source
Device Recall
External ID
Z-1696-2024
Action Date
2024-05-08
Status
Ongoing
Category
device
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
Lot/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
Quantity Affected: 58 units
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, France, Germany, Iceland, Netherlands, South Korea, Spain, Switzerland, Taiwan.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-11
Company
Norwood, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 175 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Advanced Instruments, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Advanced Instruments, LLC have FDA actions?
This is the only FDA action we have on record for Advanced Instruments, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1696-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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