Beckman Coulter, Inc. has recalled 149 units of the Access Cortisol assay due to a software error in the protocol file. This error causes the system to use incorrect calibration settings, which can lead to a high rate of calibration failures depending on the reagent lot. If the system fails to calibrate, measurement results for patient cortisol levels will be delayed, which could lead to potential injuries through delayed treatment or diagnosis.
The incorrect parameters prevent the assay from properly calibrating, which stops the system from reporting cortisol levels. This delay in reporting can be critical for patients needing urgent medical assessment. No injuries have been reported to date.
Corrective action or return.
Recall affects the Access Cortisol assay protocol file (APF) parameters.
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
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