Customer reporting on behalf of husband.Individual received a false positive result on (b)(6) 2022 using the cue covid-19 test for home and over the counter (otc) use cartridge sn (b)(4), lot 22493d, reader sn (b)(4).Repeat cue covid-19 test performed on (b)(6) 2022 provided a negative result.On (b)(6) 2022, the individual tested negative with lucira-nasal swab test and accula sars-cov-2 rt- pcr nasal swab test.The customer reported the individual¿s symptoms included a sore throat and feeling tired.The cartridges were stored according to the instructions for use.
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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 positive test and a member of the technical support group was able to perform data analysis.Investigation summary: 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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