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 positive test and a member of the technical support group was able to perform data analysis.The complaint history was reviewed and there were no previous 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 reported receiving a false positive result on (b)(6) 2023 when using the cue covid-19 test for home and over the counter (otc) use cartridge sn (b)(4) lot 26468f, reader sn (b)(4).A repeat cue covid-19 test performed on the same day provided a negative result.Customer tested negative on (b)(6) 2023 with a binaxnow antigen test and on (b)(6) 2023 with a molecular pcr test.Customer had no known exposure, but did have fatigue and headaches for 2-3 days before the test.Cartridges were stored within the validated temperature range.
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