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 20259j, reader sn (b)(4)).A repeat cue covid-19 test performed on (b)(6) 2022 provided a positive result.Customer had no known exposures and is symptomatic experiencing weakness, fever and a cough.Cartridges have been stored within the validated temperature range.
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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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