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 negative test and a member of the technical support group was able to perform data analysis.Investigation summary: the complaint history was reviewed and there was one similar complaint 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 received a false negative result on (b)(6) 2022 using the cue covid-19 test for home and over the counter (otc) use (cartridge sn (b)(4), lot 24205d, reader sn (b)(4)).The customer tested positive for covid-19 with binaxnow, intelliswab, and an unspecified ¿clinic test¿; test dates are unknown.The customer did not respond to technical support attempts to collect additional information.No further information including outside confirmatory test dates.
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