A customer complaint prompted an investigation by our company into potential product malfunction.We ran 10 control tests on the customer's product using one touch ultra control solution and a one touch ultra 2 meter.We then calculated the mean of those results and found them to be out of range.We then had retains from the same lot of product tested by a 3rd-party (initial reporter) at a low glucose level and a high glucose level.The strip readings were compared to the glucose levels, which were measured using a ysi 2300 stat plus glucose analyzer.By this method, it was determined that the retain sample product was giving falsely high results at both the low and high glucose levels.
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