Focus diagnostics has received a total of 34 complaints from 20 customers for early cycle threshold (ct) issues with the direct amplification disc (dad) (mol1455, mol1451, and mol 1452) while performing the simplexa hsv 1 & 2 direct assay.This error may result in a false positive result, a false negative result, and error code(s) giving an invalid run.Early internal testing reproduced the early ct threshold; however, these early ct were produced only when the dad was used after a previous partial run.The false result was not reported to the doctor.There was no patient involvement.A voluntary recall has been performed related to the reported lot.As of march 10, 2016, there has been no report of patient injury or death.
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