The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 14-feb-2022.Investigation summary: this statement is to summarize the investigation results regarding your complaint that alleges discrepant results (1 sample false negative, and 7 samples false positive) when using kit grp a strep 30 test veritor (material # 256040), batch number 1123931 and unidentified batch numbers.Bd quality performs a systematic approach to investigate discrepant results complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation and testing were performed on the batch number provided.Returned product testing was completed and all devices had normal intended results.The reported issue was unable to be confirmed.The root cause could not be identified.No trend against discrepant results was identified.Currently no adverse trend for discrepant results was identified.Bd quality will continue to closely monitor for trends.H3 other text : see h10.
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