The customer observed discrepant architect sars cov-2 igg results when performing a lot-to-lot comparison.The customer stated 17 samples were run over the course of 3 days, however only had 5 samples to provide.The reference range: < 1.40 s/co is negative, >/= 1.40 s/co is positive.Sample #1: 0.51 s/co (previous lot) / 0.29 s/co (new lot) sample #2: 1.84 s/co (previous lot) / 0.90 s/co (new lot) sample #3: 15.65 s/co (previous lot) / 9.06 s/co (new lot) sample #4: 2.46 s/co (previous lot) / 1.62 s/co (new lot) sample #5: 0.04 s/co (previous lot) / 0.02 s/co (new lot) the customer believes that the results generated from the new reagent lot are questionable.One sample (sample #2) out of the 5 samples provided was false negative for sars cov-2 igg.The other 4 samples were reviewed and do not meet reportability criteria.There was no impact to patient management reported.
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The complaint investigation for falsely depressed architect sars-cov-2 igg results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.A ticket search for lot 40132fn00 and a sublot 40132fn search with did not identify an increase in complaint activity related to falsely depressed results.Tracking and trending data were reviewed and did not identify any related trends.Clinical sensitivity and clinical specificity testing were performed using an in-house retain kit of complaint lot 40132fn00.All specifications were met indicating the lot is performing acceptably.The device history record review was performed on lot 40132fn00, which did not show any potential non-conformances, deviations, or non-conformances.Labeling was reviewed and found to adequately address the issue of falsely depressed results the customer's issue.Based on the investigation, no systemic issue or product deficiency for architect sars-cov-2 igg reagent lot 40132fn00 was identified.
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