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U.S. Department of Health and Human Services

Class 2 Device Recall CellMek SPS

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 Class 2 Device Recall CellMek SPSsee related information
Date Initiated by FirmDecember 23, 2025
Date PostedFebruary 02, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1235-2026
Recall Event ID 98207
Product Classification Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis - Product Code PER
ProductCellMek SPS Sample Preparation System, REF: C44603, with software
Code Information UDI-DI: 15099590750312. Software Version 2.3.90.0
FEI Number 3000203293
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
11800 Sw 147th Ave
Miami FL 33196-2500
For Additional Information ContactKristin Godfredsen
760-419-7078
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Software change control
ActionOn 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
Quantity in Commerce50
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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