H.6 investigation summary: this statement is to summarize the investigation results regarding a complaint that alleges false positive results when using kit grp a strep 30 test veritor (material # 256040), batch number unknown.The customer reported that they have detected an increase in positive results for the strep kit that do not match with patient symptoms.They disposed of the kit box, so they were unable to provide a lot number.Bd quality performs a systematic approach to investigate all false positive complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.Batch history record (bhr) review and retain sample testing could not be performed as no batch number was provided.No photos or physical samples were received; therefore, return sample analysis could not be performed.The reported issue was unable to be confirmed.The root cause could not be identified.Currently no adverse trend for false positive was identified.Bd quality will continue to closely monitor for trends.If you have any additional questions or concerns, please do not hesitate to contact bd technical services.
|