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FreezePoint® Freezing Point Osmometer
ELITECHGROUP INC. · Model Model 6000P · UDI-DI 03661540304729
10
510(k) clearances
0
Adverse events
3
Recalls
11
Facilities
Description
FreezePoint Freezing Point Osmometer is intended for laboratory use by qualified personnel for the determination of total osmolality of aqueous solutions.
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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