Explanation for device evaluated by mfr: 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 test and a member of the technical support group was able to perform data analysis.The complaint history was reviewed and there were no similar complaints against involved lot.The lot history record (lhr) was reviewed for the lot number in the complaint, and it passed release specifications.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 received a false negative result on (b)(6) 2022 using the cue covid-19 test for home and over the counter (otc) use cartridge sn (b)(4), lot 19940f, reader sn (b)(4).On (b)(6) 2022, customer tested positive with an abbott binaxnow rapid antigen test and a sars-cov-2 pcr test.Customer was symptomatic with a fever and strong cough.Cartridges stored within the validated temperature range.On (b)(6) 2022, customer stated they were on day 14 of having covid-19.
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