The investigation determined that the reagent and conjugate bottles were switched within the vitros cov2tot lot 0027 reagent pack.This issue is associated with investigation fi 471026 (anti sars cov 2 total and anti sars cov 2 igg reagent pack bottles switched).A customer communication ((b)(4)) was sent 17 july 2020 to all customers who were shipped affected lots of vitros anti-sars-cov-2 total and vitros anti-sars-cov-2 igg reagent.The letter indicates if the two reagent bottles are interchanged (swapped), the correct reaction scheme does not occur.This can result in false negative results for a sample that is reactive, calibration failures and quality control failures for the reactive control.The letter instructs customers to visually inspect the reagent pack prior to loading to ensure correct reagent bottle configuration.The fda was notified of this issue on wednesday 15 july 2020.Refer to report number (b)(4).
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