Beckman Coulter Recalls CellMek SPS Sample Preparation System Due to Software Error
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Beckman Coulter, Inc. has issued a voluntary recall for 50 CellMek SPS Sample Preparation Systems due to a software glitch that could lead to incorrect patient diagnoses.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
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).
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.