Diagnostica Stago, Inc. has recalled 369 units of its STA Liatest Free Protein S kits because they may underestimate free protein S levels in normal patient blood samples. These kits are diagnostic tools used in laboratories to measure protein S levels using specialized instruments. Because the defect specifically affects results in the normal range, it could lead to incorrect medical assessments, although the company is voluntarily initiating this correction to address the out-of-range findings.
The defect causes an underestimation of protein S levels in patients who actually have normal levels, which could lead to a false clinical picture. No specific patient injuries or incidents have been reported in the provided data.
Intended for use on STA-R and STA Compact instruments for quantitative antigenic assay of free protein S in human citrated plasma.
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.