Becton Dickinson & Co. is recalling 23 units of the BD Kiestra Urine Culture Application powered by BD Synapsys Informatics Solution. This diagnostic software is being recalled because the digital image colony count may not accurately reflect the actual number of colonies on the physical culture plate. This discrepancy can lead to inaccurate lab results which directly impact patient diagnosis and the subsequent course of medical care.
If the software provides an inaccurate colony count, healthcare providers may misdiagnose a patient's condition or prescribe an incorrect treatment plan based on flawed laboratory data.
Manufacturer notification and potential software update.
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.