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Advanced Instruments OsmoPRO Multi-Sample Micro-Osmometer

Advanced Instruments, LLC · Model OsmoPRO · UDI-DI 00816068020559

JJM
10
510(k) clearances
0
Adverse events
3
Recalls
11
Facilities

Description

Supporting efficient workflows for mid- to high-volume clinical chemistry labs, the OsmoPRO features a convenient carousel design that handles up to 20 samples, an intuitive touchscreen interface, and industry-leading performance. Simple, reliable, and efficient, the OsmoPRO delivers accurate and precise analysis of patient samples for maximum productivity.

Recalls

DateFirmReason
2024-03-11Advanced Instruments, LLCSystem 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.
2007-12-26Wescor, IncInaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.
2007-12-26Wescor, IncInaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.