An investigation was performed for the customer issue and included a review of the complaint text, search for similar complaints, a review of trending data, a review of historical performance of lot 32860un18, review of patient data, and a review of product labeling.A search by lot number identified two other similar complaints that were not a deficiency.The trend review determined there are no adverse trends or non-statistical trends related to this issue.World wide data was used to evaluate the historical performance of lot 32860un18.Patient data was evaluated and indicated the patient median result for lot 32860un18 is within established control limits and no unusual lot performance was identified.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.
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