Roche Diagnostics has recalled 6,504 units of its Creatine Kinase (CK) Assay used on cobas c 311/501/502 and COBAS INTEGRA 400 plus laboratory analyzers. The recall was initiated because abnormal calibrations on these specific analyzers may lead to incorrect test results. These erroneous results could potentially lead to a medical misdiagnosis for patients being tested for heart or muscle damage.
Abnormal calibration of the testing equipment can cause the device to produce inaccurate measurements of creatine kinase in human serum and plasma. This poses a risk of incorrect medical treatment or delayed diagnosis if a healthcare provider relies on the faulty test data.
Contact healthcare provider or manufacturer
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.