Recall Z-1696-2024— Advanced Instruments, LLC
Class II · Ongoing
Class II FDA medical device recall by Advanced Instruments, LLC, initiated 2024-03-11. FDA's recall record names no specific 510(k) clearance for this event. Product: OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serum, plasma, and urine. Model/Catalog Number: OsmoPRO MAX Software Version: 1.5.0.0. Reason: 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..
- Recalling firm
- Advanced Instruments, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-11
- Firm location
- Norwood, MA, United States
Product description
OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serum, plasma, and urine. Model/Catalog Number: OsmoPRO MAX Software Version: 1.5.0.0
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.