Siemens Healthcare Diagnostics, Inc. has recalled 559 units of the Atellica CI Analyzer due to a software issue that can cause incorrect patient test results. The analyzer may incorrectly show that it has enough testing fluid (IMT Diluent) remaining when it is actually empty. If the analyzer continues to run while empty, it can produce falsely elevated results for Sodium (Na), Potassium (K), and Chloride (Cl). This recall affects analyzers with catalog number 10947347 running software version 1.28.51. No incidents or injuries have been reported.
If the analyzer runs out of diluent without alerting the operator, it may produce inaccurate results for essential electrolytes. Falsely high readings for sodium, potassium, or chloride could lead to incorrect medical diagnoses or inappropriate treatments for patients.
Potential that the IMT Diluent volume remaining does not decrease as expected.
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.