Udi: (b)(4).The customer indicated that their statstrip wireless meter reported glucose result that was high compared to the readings reported from another meter.Dhr reviews for the statstrip glucose meter, sn (b)(6), and statstrip glucose test strips, lot 0321243249, were performed by the sr.Quality control manager.The reviews included an assessment of the production, testing, and release of the meters and test strip batch.No abnormalities or concerns were observed; the dhrs indicated that the released product met all specifications.The nova clinical applications department performed a mini correlation study which concluded that the statstrip glucose meter, sn (b)(6), has a good correlation to the laboratory reference method.The meter meets the recommended poct12-a3 clinical accuracy standard.Retain statstrip glucose test strips, lot 0321243249, met the performance acceptance criteria for linearity and whole blood specimens.All linearity results were within range and no discrepant results were observed for whole blood samples.No further action is required at this time, nova will continue to monitor for recurrence.
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