← FDA ENFORCEMENT
Z-1235-2026Class II

Beckman Coulter, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Beckman Coulter, Inc.
Product type
Device
Status
Ongoing
Report date
2026-02-11
Distribution
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.
Firm state
FL
Product quantity
50
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Data Integrity
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.

Product description

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

Code / lot info

UDI-DI: 15099590750312. Software Version 2.3.90.0

Other recalls SPEQ maps to Data Integrity
See all Data Integrity recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →