Beckman Coulter recalls CellMek SPS Sample Preparation System software versions 2.2.122.0 and prior with incorrect dead volumes that may lead to incorrect diagnosis or treatment errors.
Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.
Beckman Coulter is recalling CellMek SPS Sample Preparation Systems with specific software versions and instructions for use that list incorrect dead volumes. This could lead to incorrect diagnosis or errors in patient treatment.
The software lists incorrect dead volumes for specific cassette types, which may cause inaccurate measurements. When used with 15mmX92mm Sarstedt tubes, this could lead to incorrect diagnosis or treatment errors.
Laboratory users with CellMek SPS systems using software versions 2.2.122.0 and prior or IFU revisions AD and prior are most at risk. The affected units include those with Cassette E and serial numbers from BE43003 to BJ18014.
Check for software versions 2.2.122.0 and prior or IFU revisions AD and prior. Affected units have serial numbers between BE43003 and BJ18014, manufactured from December 2021 to April 2025.
Verify your CellMek SPS software version; if it is 2.2.122.0 or earlier, it is affected.
Check if your instructions for use are revisions AD or earlier; affected units include Cassette E.
Software versions 2.2.122.0 and prior are affected.
The recall does not specify a remedy, so you should contact Beckman Coulter for guidance.
Serial numbers from BE43003 to BJ18014, manufactured from December 2021 to April 2025.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0412-2026 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0412-2026 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.
