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A20 Advanced Automated Osmometer

Advanced Instruments, LLC · Model A2O · UDI-DI 00816068020641

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

Description

Built to keep the busiest labs productive, the A2O Advanced Automated Osmometer combines exceptional analytical performance with full automation. Laboratories can depend on the A2O to deliver accurate and precise osmolality measurements while maximizing walk-away time.

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.