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Advanced Instruments Osmo1® Single-Sample Micro-Osmometer
Advanced Instruments, LLC · Model Osmo1 · UDI-DI 00816068020542
10
510(k) clearances
0
Adverse events
3
Recalls
11
Facilities
Description
With the Osmo1 Single-Sample Micro-Osmometer, we’ve bundled together accurate and reliable osmolality measurement with ease-of-use for efficient patient sample analysis. Easily maintain regulatory compliance while ensuring the security and integrity of patient data with the Osmo1. Best for labs that process 10 or fewer samples per day or prefer a direct-draw instrument.
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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