Beckman Coulter, Inc. is recalling 50 units of the CellMek SPS Sample Preparation System due to a software error in version 2.3.90.0. The error causes samples to be dispensed too close to the bottom of the tube, which can dislodge fluid lines and lead to sample loss or spillage. This defect results in the unintentional removal of 60-100 microliters from the final sample, which could make the instrument inoperable or lead to incorrect medical diagnoses.
The software malfunction causes fluid lines to be dislodged when they touch the tube bottom, resulting in inaccurate sample volumes. This specific loss of sample material can lead to incorrect diagnostic results, potentially causing improper patient management or delayed treatment.
Recall #: Z-1235-2026. Includes software version 2.3.90.0.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.