Diagnostica Stago, Inc. has recalled 939 units of its STA - Owren Koller buffer solution (Model 00360) because it may cause blood clotting tests to overestimate results by approximately 1%. This buffer is used as a liquid diluent for clinical blood tests performed on various laboratory analyzers, including the STA-R and STA Compact families. No injuries or incidents have been reported to date regarding this issue.
The buffer solution may cause shorter-than-intended clotting times in tests that require dilution. This could lead to a minor inaccuracy in diagnostic results, potentially affecting clinical decisions based on those blood tests.
Intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.
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.