Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, labeling review, and device history review.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.Device history review did not identify any issues that may have caused the customer issue.Review of the customer issue determined the specimens were not recentrifuged prior to testing.The customer stated the on board detergent washes are topped off and that the sample washes were not replaced daily.The operations manual maintenance procedures include instructions to change sample washes daily and to not top off reagents.No further discrepant results were noted and the quality controls were reported to be in range.Based on all available information and abbott diagnostics evaluation, no systematic issue was identified and no product deficiency was identified.
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