Beckman Coulter, Inc. recalls CellMek SPS Sample Preparation System

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.

On 12/23/2025, recall notices were mailed and emailed to customers who were asked to do the following: 1) To mitigate the risk of contact between the dispense probe and the tube bottom, utilize CellMek SPS output tubes distributed by Beckman Coulter. 2) For absolute count assays, use the CellMek SPS on-board counting bead feature. Do not add counting beads to samples manually after preparation with CellMek SPS. 3) Share the content of this letter with your laboratory and/or medical director regarding the need to review previous patient test results. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. 4) Firm recommends posting this letter on or near the affected instruments. 5) Complete and return the response form. Firm will perform an on-site service modification to update your instrument software to correct this issue. If you have any questions regarding this notice, please contact the firm's Customer Support Center: http://www.beckman.com, (800) 369-0333

• FDA enforcement recordOfficial FDA database entry for Z-1235-2026
• FDA device classification · PEROfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.2750The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Beckman Coulter, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.