United StatesThe recall affects the CellMek SPS Sample Preparation System (REF C44603, UDI‑DI 15099590750312) with software Version 2.3.90.0; 50 units were distributed worldwide including specified U.S. states and several countries. It was recalled because a software error can cause sample dispensing near or touching tube bottoms, potentially dislodging fluid lines, causing sample loss or spillage, making the instrument inoperable and unintentionally removing 60–100 microliters from the final sample, which may lead to incorrect diagnosis or patient management.
What's being recalled
CellMek SPS Sample Preparation System, REF: C44603, with software
Recalling firm: Beckman Coulter, Inc., Miami, FL, United States.
How to identify it
UDI-DI: 15099590750312. Software Version 2.3.90.0
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada