FDA-Device2026-02-11Class II
CellMek SPS Sample Preparation System, REF: C44603, with software
Beckman Coulter, Inc.
Hazard
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.
Sold states
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.
Affected count
50
Manufactured in
11800 Sw 147th Ave, N/A, Miami, FL, United States
Products
CellMek SPS Sample Preparation System, REF: C44603, with software
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1235-2026Don't want to check this manually?
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