Customer returned the products in question for further testing.Review of manufacturing and qc records indicated that the products were manufactured without issue and met all the product release criteria.The returned strips and the retention sample of ther reported lot were tested with urine control solution and clinical samples.These were compared to siemens multistix.The restuls of both the returned product and the retention sample showed no anomalies.Although the returned strips showed a result of half a block difference, it was still within the acceptable criteria.Based on the batch record review and the product test results, the root cause could not be determined.No further investigation required as the frequency of occurrence of the complaint is improbable and the severity is negligible.We will continue to trend for similar complaints in the future.
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