Customer reported on behalf of an unknown individual.Individual received a false positive result on (b)(6) 2022 using cue covid-19 test for home and over the counter (otc) use cartridge lot 16126d.The individual received two negative cue covid-19 results; date unknown.The individual did not take an outside confirmatory test, had no symptoms, or confirmed covid-19 exposure.The cartridges were stored according to the instructions for use.No further information available including patient specific information, cue cartridge serial number or cue reader serial number.
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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 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.Root cause was undetermined.
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