Evaluation of complaint data for the lots identified normal complaint activity.A review of the manufacturing documentation did not identify any issues associated with the customer observation.Labeling was reviewed and found to adequately address the issue.A review of the prism metrics field data for the abbott prism chagas lot 68048m500 was performed for specificity.A total of 443,845 samples were tested across multiple customer sites and the initial and repeat (b)(4), respectively, which are less than the prism chagas package insert upper 95% confidence intervals of 0.28% and 0.23%.Therefore, the lot is meeting labeling claims for clinical specificity.A malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.However, a systemic issue and/or product deficiency was not identified.
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