⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Beckman Coulter, Inc.: CellMek SPS Sample Preparation System, REF: C44603, with software

Medical DevicesSource: FDA (device) · Date: 2026-02-11

Read the official notice at FDA (device) →

Share on XFacebookRedditEmail

Get alerts for Beckman Coulter

Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Beckman Coulter, Inc.
Product
CellMek SPS Sample Preparation System, REF: C44603, with software
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2025-12-23
Code info
UDI-DI: 15099590750312. Software Version 2.3.90.0
Product quantity
50
Voluntary mandated
Voluntary: Firm initiated
City
Miami
State
FL
Country
United States
Event id
98207
Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.