Customer received two false negative results on (b)(6)2022 using the cue covid-19 test for home and over the counter (otc) use (cartridge sn (b)(4) and 152274340, lot 21405i, reader sn (b)(4)).The customer tested positive with three ihealth self-test at home on (b)(6) 2022.The customer reported they had a sore throat, runny nose, fever, aches, and pain symptoms.
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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.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.Root cause was undetermined.
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