Advanced Instruments, LLC recalls OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measur…

Recall date

March 11, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1696-2024

FDA classification

Class II

Brand / firm

Advanced Instruments, LLC

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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