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
Reported: May 8, 2024 Initiated: March 11, 2024 #Z-1696-2024
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.
Details
- Recalling Firm
- Advanced Instruments, LLC
- Units Affected
- 58 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, France, Germany, Iceland, Netherlands, South Korea, Spain, Switzerland, Taiwan.
- Location
- Norwood, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Advanced Instruments, LLC. Units affected: 58 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 8, 2024. Severity: Moderate. Recall number: Z-1696-2024.
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