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 tests and a member of the technical support group was able to perform data analysis.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 reported that her daughter received two (2) false negative results using the cue covid-19 test for home and over the counter (otc) use.This report is to document the false negative that occurred (b)(6) 2022.See case-2022-1527-1 for alternate false negative result.Customer reports individual received a false negative result on (b)(6) 2022 when testing with the cue covid-19 test for home and over the counter (otc) use (cartridge sn (b)(4) lot 22008b, reader sn (b)(4).On (b)(6) 2022, customer tested positive with an unspecified brand of at-home test.On (b)(6) 2022, customer tested positive with a binaxnow antigen test and with an indicaid at-home test.On (b)(6) 2022, an additional binaxnow antigen test was performed and a positive result was obtained.Individual has mild symptoms (sore throat).
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