Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incorrect diagnosis or patient management.
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Recall Number
Z-1235-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-12-23
Reported
2026-02-11
Distribution
Worldwide - US Nationwide distribution in the states of MO, WA, MA, IL, AL, OR, IL and the countries of AB, BE, ES, FR, NL, ON, DE, AT, VIC, AU, GB, SK, MX, CH.
Code Info
UDI-DI: 15099590750312. Software Version 2.3.90.0
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.