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 positive 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.
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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 20849j, reader sn (b)(4).Repeat cue covid-19 test performed on 07-aug-2022 provided a negative result.The customer tested negative with an unspecified covid-19 antigen test on (b)(6) 2022 and with accula sars-cov-2 pcr test on an unknown date.The customer reported he is experiencing mild symptoms including a running nose (a week ago, may have been allergy), mild stomach discomfort, feverishness (no actual fever), tightness of the throat, extra phlegm, lightheadedness, tiredness, slightly green mucus, and very mild nosebleeds.Customer expressed all of the symptoms have been mild and relatively common to him.The customer reported the cartridge storage temperature may have reached 90 degrees fahrenheit.
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