Evaluation of complaint data for the architect insulin reagent lot 73020lp89, determined that there is normal complaint activity and no trends for the reported issue.Accuracy testing was performed with a retained kit of lot 73020lp89 and all acceptance criteria was met.A review of labeling was found to adequately address the issue.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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