The investigation determined that a higher than expected vitros tsh result was obtained from a patient sample during a patient correlation which was processed as part of troubleshooting using vitros tsh reagent lot 6180 on a vitros 5600 integrated system.The most likely assignable cause of the higher than expected patient sample result is an issue related to pre-analytical sample handling.It was confirmed that several of the patient samples processed including patient sample 9 were not re-centrifuged before being re-processed using vitros tsh lot 6180 and the serum was likely not separated from the cellular material.However, an issue related to pre-analytical handling could not be entirely confirmed.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros tsh reagent lots 6180.
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