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FDAMarch 11, 2024device

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 recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

advanced instrumentsadvanced

UPCs

00816068021150

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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