Beckman Coulter Recalls CellMek SPS Sample Preparation System Due to Software Error

What Happened

Beckman Coulter, Inc. has initiated a voluntary recall of the CellMek SPS Sample Preparation System due to a software error in version 2.3.90.0. The system, which is designed to automate staining, lysing, and cell washing, may dispense samples too close to or touching the bottom of tubes. This defect can dislodge fluid lines, cause sample loss or spillage, and render the instrument inoperable. Most critically, the error can lead to the unintentional removal of 60-100 microliters from the final sample, which may result in incorrect medical diagnoses or improper patient management.

Which Products Are Affected

The recall involves the following medical device equipment:

• Product Name: CellMek SPS Sample Preparation System
• Reference Number: REF: C44603
• Software Version: 2.3.90.0
• UDI-DI: 15099590750312
• Recall Number: Z-1235-2026
• Quantity: 50 units

The affected units were distributed in the U.S. states of Alabama, Illinois, Massachusetts, Missouri, Oregon, and Washington. International distribution includes Austria, Australia (VIC), Belgium, Canada (AB, ON), Switzerland, Germany, Spain, France, Great Britain, Mexico, Netherlands, and Slovakia.

What You Should Do

Beckman Coulter, Inc. notified customers of the issue via a formal letter sent on December 23, 2025. Users of the CellMek SPS Sample Preparation System should verify if their equipment is running software version 2.3.90.0 and follow the instructions provided in the firm’s notification. For additional information, the recalling firm is located at 11800 Sw 147th Ave, Miami, FL 33196-2500.

Why This Matters

This recall is significant because the software defect can compromise the integrity of clinical samples. The resulting loss of sample volume poses a risk of incorrect diagnostic results, which could lead to inappropriate medical treatment or patient management decisions.

Source

Information provided by the FDA (Recall Event ID: 98207).