BEUDAMED
    FDA Recall Open, Classified

    CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.

    Recall: Z-0412-2026 · Initiated September 8, 2025

    Recall

    Recall Number
    Z-0412-2026
    Event Number
    97531
    Firm
    Beckman Coulter, Inc.
    FEI Number
    3000203293
    Product Code
    PER
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    September 8, 2025
    Posted
    October 30, 2025
    Address
    11800 Sw 147th Ave, Miami, FL, 33196-2500

    Description

    CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.

    Reason

    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.

    Action

    Beckman Coulter notified consignees via email and letter on about 09/08/2025. For Issue 1 (Incorrect Dead Volumes), consignees were instructed to use the actual specimen dead volumes stated in Issue Description in the notification letter when processing samples in CellMek SPS with Sarstedt brand tubes. Beckman Coulter recommends sharing the content of the notification letter with laboratory and/or medical director regarding the need to review previous patient test results that were generated using the Sarstedt brand tubes. Beckman Coulter also recommends posting this letter on or near the affected instruments. Beckman Coulter will provide the correct CellMek SPS specimen dead volumes for Sarstedt brand tubes (Cassette Types B and E) in the next revision of the CellMek SPS Instructions for Use For Issue 2 (), consignees were instructed not to use Cassette Type E (15mm X 92mm Sarstedt brand tubes) to process samples on CellMek SPS. Beckman Coulter recommends sharing the content of the notification letter with laboratory and/or medical director regarding the need to review previous patient test results that were generated using the Sarstedt brand tubes. Beckman Coulter recommends posting the notification letter on or near the affected instruments. Beckman Coulter is actively investigating this issue and plans to address it in a future product release. Additionally, customers were instructed to notify personnel/customers if any affected units were transferred/distributed to another laboratory, and to complete and return the response form.

    Distribution

    Worldwide - US Nationwide distribution in the states of AL, AR, FL, IL, IN, MA, ME, MI, MN, MO, NY, OR, TN, UT, WA and the countries Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Korea, Republic of, Mexico, Morocco, Netherlands, Poland, Portugal, Puerto Rico, South Africa, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland.

    Quantity

    108 units