An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, architect havab igg, list 6c29, that has a similar product distributed in the us, havab-g, list number 6l27.
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An investigation was performed for the customer issue and included a review of the complaint text, service history, ticket trending, evaluation of performance regarding specificity, a review of field data and product labeling.Ticket searches determined that there is a trend in complaint activity for lot numbers 92421li00/92425li00 regarding false reactive patient results.During the 12 months tracking and trending review, adverse and non-statistical trends were identified for the complaint issue during the reviewed timeframe.To evaluate performance with regard to specificity, retained kits of reagent lot number 92421li00 were tested in a specificity set-up.All control values met specifications and no false reactive results were obtained.The generated data does not indicate that the reagent lot is compromised.A review of field data determined that the number of standard deviations to the cut-off for the negative population is within established limits.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics complaint investigation, no product deficiency was identified.
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