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Advanced Instruments, LLC recalls OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure
Recalled May 8, 2024 · FDA recall Z-1696-2024 · Advanced Instruments
Hazard
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. · FDA Class II
Units
58 units
Sold at
Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, France, Germany, Iceland, Netherlands, South Korea, Spain, Switzerland, Taiwan.
Description
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.
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
Manufacturer(s)
Advanced Instruments, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →