Beckman Coulter recalls CellMek SPS Sample Preparation System with software error causing sample loss and potential incorrect diagnosis. Affected units have specific model and software version.
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.
Beckman Coulter is recalling its CellMek SPS Sample Preparation System due to a software error that can cause samples to be dispensed too close to tube bottoms. This may lead to fluid line dislodgement, sample loss, spillage, and incorrect patient diagnosis.
The software error causes samples to be dispensed close to or touching tube bottoms. This can dislodge fluid lines, leading to sample loss, spillage, instrument inoperability, and potential incorrect diagnosis or patient management.
Users of the CellMek SPS Sample Preparation System with software version 2.3.90.0 are affected. Laboratory technicians and medical professionals using this system for sample preparation are most at risk.
Check for the CellMek SPS Sample Preparation System with software version 2.3.90.0. The product has a UDI-DI number 15099590750312.
Verify the software version on your CellMek SPS system. If it is 2.3.90.0, it is affected.
The affected software version is 2.3.90.0.
The error causes samples to be dispensed close to tube bottoms, which can dislodge fluid lines, lead to sample loss, spillage, and potential incorrect diagnosis.
The recall record does not mention a remedy or fix.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1235-2026 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1235-2026 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
