Customer reported that they received a false positive result on (b)(6) 2022 when testing with cue covid-19 test for home and over the counter (otc) use (cartridge sn: (b)(4), lot: 24215f, reader sn: (b)(4).Three repeat cue tests performed on the same day provided negative results.On (b)(6) 2022, customer tested negative with two confirmatory antigen tests (brand unknown).Customer has low grade fever with no additional symptoms.Cartridges had 87 degree fahrenheit exposure.Temperature tracker on package from google indicates package reached high exposure temperature.Advised customer of recommended cartridge storage temperature per ifu.
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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 positive test and a member of the technical support group was able to perform data analysis.The complaint history was reviewed and there were two 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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