A review of tickets determined that there is normal complaint activity for lot 58505uq11.Trending review determined no trend identified for falsely depressed results for the product.Return testing was not completed as returns were not available.Maintenance of the non-abbott water quality system and re-establishing the required product water quality to the instrument corrected the results issue.Results were returned to expected levels.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.The device history record review identified no non-conformances or deviations related to the complaint issue.A review of the labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the architect carbon dioxide reagent, lot number 58505uq11 was identified.
|