The customer reported ten (10) false positive results with the determine hiv 1/2 ag/ab combo 25t on unknown dates.This report is for patient seven (7) of ten (10).The patient tested positive with the determine hiv 1/2 ag/ab combo however confirmation testing (unknown brand and platform) generated a negative result.No additional patient information, including treatment and outcome, was provided.
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This supplemental report is being submitted to provide the investigation conclusion.Please see updates: g3, g6 and h2.The customer was unable to provide the required intake information.The information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, complaints against these trend codes are monitored to identify and track any out-of-trend/unexpected performance at the lot and product family level.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.
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