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 tests 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.Customer complaint was not confirmed during the investigation.Root cause was undetermined.
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Customer reports husband received two false negative results on (b)(6) 2022 using the cue covid-19 test for home and over the counter (otc) use (cartridge sn (b)(4), lot 19521f, reader sn (b)(4)).On (b)(6) 2022, individual tested positive with the ihealth antigen test.On (b)(6) 2022, individual tested positive again with the ihealth antigen test.Individual had symptoms (coughing) starting on (b)(6) 2022.Cartridges were stored within the validated temperature range.
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