Beckman Coulter, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0412-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: September 8, 2025

Date Posted: November 5, 2025

Recall Number: Z-0412-2026

Event ID: 97531

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 108 units

Code Information:

All serial numbers between BE43003 through BJ18014, manufactured from 12/03/2021 to 04/15/2025. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated