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 were five 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.Root cause was undetermined.
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Customer received a false positive result on 18-aug-2022 using the cue covid-19 test for home and over the counter (otc) use cartridge sn (b)(4) lot 23874l, reader sn (b)(4).A repeat cue covid-19 test performed on (b)(6) 2022 provided a negative result.Customer tested negative with an ellume covid-19 antigen test on (b)(6) 2022.Customer experienced symptoms of fatigue, headache and chest pain.Cartridges were stored according to the instructions for use.
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