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 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 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 received a false negative result on (b)(6) 2023 using the cue covid-19 test for home and over the counter (otc) use (cartridge sn (b)(4), lot 26499b, reader sn (b)(4) ).The same day, the customer tested positive two times with binaxnow covid-19 ag card tests and once with an unknown covid-19 antigen test.Repeat cue covid-19 test performed on (b)(6) 2023 provided a positive result.Customer reported sore throat, no known exposure, and confirmed the cartridges were stored according to the instructions for use (70 degrees f).
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