Immunotech A.S. has recalled 279 units of its Estrone RIA kits (Catalog Number DSL8700) because they may produce falsely high or low results for patients. These kits are laboratory tools used by medical professionals to measure hormone levels in human blood samples. While the risk of an incorrect result is low, it could lead to improper medical diagnosis or treatment decisions.
Falsely high test results can lead to temporary medical concerns, while falsely low results could potentially cause permanent injury due to incorrect clinical management. No incidents or injuries have been reported at this time.
Manufacturer return/replacement
An in vitro diagnostic manual medical device used for the quantitative measurement of estrone in human serum and 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.