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 tests and a member of the technical support group was able to perform data analysis.The complaint history was reviewed and there was one previous similar complaint against involved lot.The lot history record (lhr) was reviewed for the lot number in the complaint, and it passed release specifications.Technical operations performed retain testing and was unable to confirm the customer complaint.No false positive results were observed.A technical support representative reviewed customer data and performed data analysis.Root cause was undetermined.
|
Customer reports false positive results for five individuals when testing with the cue covid-19 test for home and over the counter (otc) use.This report is to document one of the false positive results for individual 1.See related cases for alternate false positive results.Individual received a false positive result on (b)(6) 2023 when using the cue covid-19 test for home and over the counter (otc) use (cartridge sn (b)(4), lot 27520a, reader sn (b)(4)).Two repeat cue covid-19 tests performed on (b)(6) 2023 provided negative results.Individual tested negative on (b)(6) 2023 and (b)(6) 2023 with an unspecified covid-19 antigen test.Individual had no symptoms or known exposure.Cartridges were stored within the validated temperature range.
|