Investigation summary: the complaint investigation for discrepant result when using the bd max ct/gc/tv (ref 442970) from unknown lot was performed by the verification of complaints history.Despite multiple attempts made to receive information from the customer, no data was provided for the investigation.The investigation was thus limited.Customer reported that, over a period of 6 months, 20 out of 300 samples gave a negative result with the bd max¿ ct/gc/tv assay whereas the pap smear test showed a positive result for the tv target.Based on the available information, and without run data, bd is unable to identify a cause for the customer discrepant results.Nonetheless, no reagent issue is suspected.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max ct/gc/tv products.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.H3 other text : see h10.
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