The investigation has determined that lower than expected lactate (lac) results were obtained from a non-vitros biorad quality control fluid and a vitros performance verifier using vitros chemistry products lac slides lot 3532-0115-2784 on a vitros 5600 integrated system.The assignable cause of the lower than expected vitros lac results was a suboptimal calibration.The parameters from the initial calibration of reagent lot 3532-0115-2784 used to obtain the lower than expected results were atypical compared to the database values.Following a recalibration event, vitros lac calibration parameters and quality control results returned to expectations.The cause of the suboptimal calibration was not determined.Freshly prepared vials of vitros calibrator kit 1 lot 0131 were used for the recalibration event.Calibrator fluid preparation of the initial vials was a possible contributor of the suboptimal calibration, however this could not be confirmed or ruled out.Although precision testing was not performed on the vitros 5600 integrated system, an instrument related issue is not a likely contributor of the event as quality control results were returned to expectations after a recalibration event without any known troubleshooting actions being performed on the instrument.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros lac reagent lot 3532-0115-2784.(b)(4).
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