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Advanced Instrument OsmoPRO MAX
Advanced Instruments, LLC · Model OsmoPRO MAX · UDI-DI 00816068021150
10
510(k) clearances
0
Adverse events
3
Recalls
11
Facilities
Description
The OsmoPRO MAX provides osmolality measurement of serum, plasma, and urine, and is intended for use by trained healthcare professionals. Osmolality is a valuable clinical tool used in the diagnosis and treatment of patients. It is a quick and effective test to help evaluate the body’s water balance or its ability to produce and concentrate urine, to investigate low sodium levels (hyponatremia), to detect the presence of toxins in the body, and to monitor the osmolality of patients undergoing osmotically active drug therapies such as mannitol, which is used to treat cerebral edema.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-11 | Advanced Instruments, LLC | 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. |
| 2007-12-26 | Wescor, Inc | Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing. |
| 2007-12-26 | Wescor, Inc | Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing. |
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