FDA-Device2024-05-08Class II
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
Advanced Instruments, LLC
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, France, Germany, Iceland, Netherlands, South Korea, Spain, Switzerland, Taiwan.
Affected count
58 units
Manufactured in
2 Technology Way, Norwood, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1696-2024Don't want to check this manually?
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