Focus diagnostics has received a total of 41 complaints from 21 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 (b)(6) result, a (b)(6) 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 may 18, 2016, there has been no report of patient injury or death.
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