Response to device evaluated by manufacturer: cartridges used by the consumer were not sent back for evaluation, therefore, the devices could not be evaluated.The customer provided information regarding the suspected false negative tests and a member of the technical support group was able to perform data analysis.Complaint history was reviewed and there were two previous similar complaints against involved lot.The lhr was reviewed and the lot numbers in the complaint passed qc release.A technical support representative reviewed customer data and performed data analysis.All data values were normal and met acceptable criteria.Root cause was undetermined.
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Customer reports receiving a potential false negative result on (b)(6) 2022 when testing with the cue covid-19 test for home and over the counter (otc) use (cartridge sn (b)(4), lot 19996g, reader sn (b)(4)).Customer tested positive with a binaxnow antigen test on (b)(6) 2022, (b)(6) 2022, (b)(6) 2022 and (b)(6) 2022.Customer also tested positive with a sars-cov-2 pcr test on (b)(6) 2022 and (b)(6) 2022.Customer experiencing symptoms and states they had a known exposure.Cartridges stored within the validated temperature range.See related cases for additional false negative results.
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