Ortho-Clinical Diagnostics is recalling approximately 174,215 units of VITROS Chemistry Products Ca Slides (Generations 67 and above) used on VITROS XT 3400 and VITROS XT 7600 Systems. The recall was initiated because these slides are experiencing a significant increase in calibration failures caused by a technical error (Condition Code TH4-63J) where the system detects imperfections in the slide images. This defect can lead to failed calibrations that delay calcium test results for patients.
Delayed test results can prevent the timely diagnosis and treatment of urgent medical conditions, such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies that require immediate medical intervention.
Affected Generations (GENs): 67 and above.
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.