FDA recall Z-1696-2024

Advanced Instruments, LLC · Class II · device

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 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.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, France, Germany, Iceland, Netherlands, South Korea, Spain, Switzerland, Taiwan.

Key facts

Status
Ongoing
Initiation date
2024-03-11
Report date
2024-05-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Norwood, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1696-2024