Beckman Coulter, Inc.: Medical Device Recall in 2026 - (Recall #: Z-1235-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

CellMek SPS Sample Preparation System, REF: C44603, with software

Product Classification:

Class II

Date Initiated: December 23, 2025

Date Posted: February 11, 2026

Recall Number: Z-1235-2026

Event ID: 98207

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.

Status: Ongoing

Product Quantity: 50

Code Information:

UDI-DI: 15099590750312. Software Version 2.3.90.0

Distribution Pattern:

Worldwide - 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.

Voluntary or Mandated:

Voluntary: Firm initiated