Customer received a false positive result on (b)(6) 2022 using the cue covid-19 test for home and over the counter (otc) use cartridge sn (b)(4), lot 22679b, reader sn (b)(4).A repeat cue covid-19 test performed on the same day provided a negative result.Customer tested negative on (b)(6) 2022 and (b)(6) 2022 with two sars-cov-2 pcr tests.The customer confirmed had a sore throat but no known exposure.Cartridges were stored according to the instructions for use.
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Response to device evaluated by mfr 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 positive test 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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